“COMPARISON OF SURGICAL PLETH INDEX –GUIDED

ANALGESIA WITH CONVENTIONAL ANALGESIA WITH

DESFLURANE ANESTHESIA IN LAPAROSCOPIC SURGERIES-
A RANDOMISED DOUBLE BLINDED CONTROLLED TRIAL”

A dissertation submitted to
NATIONAL BOARD OF EXAMINATIONS,
NEW DELHI
DIPLOMATE OF NATIONAL BOARD (ANAESTHESIOLOGY)

Submitted by

DR. CHANDINI KILLARI

Under the guidance and supervision

of
Dr.S PRASHANTH REDDY

HEAD OF THE DEPARTMENT, ANAESTHESIOLOGY

DEPARTMENT OF ANAESTHESIOLOGY
YASHODA SUPERSPECIALITY HOSPITAL
HYDERABAD, TELANGANA STATE
 DECLARATION BY THE CANDIDATE

I hereby declare that this dissertation entitled “COMPARISION OF SURGICAL PLETH

INDEX GUIDED ANALGESIA WITH CONVENTIONAL ANALGESIA WITH
DESFLURANE ANESTHESIA IN LAPROSCOPIC ABDOMINAL SURGERIES”, is a
bonafide and genuine research carried out by me under the guidance of DR.S.
PRASHANTH REDDY.M.D. head of the department Anesthesiology Yashoda hospital,
Somajiguda.Rajbhavan road, Hyderabad, Telangana.

Date signature of the candidate

Place DR. CHANDINI KILLARI

CERTIFICATE BY THE GUIDE

This is to certify that the dissertation entitled “COMPARISON

OF SURGICAL PLETH INDEX —GUIDED ANALGESIA
WITH CONVENTIONAL ANALGESIA WITH
DESFLURANE ANESTHESIA IN LAPAROSCOPIC
ABDOMINAL SURGERIES” is a bonafide work done by DR.
CHANDINI.KILLARI, in the department of Anesthesiology,
Yashoda superspeciality hospital, Somajiguda, Hyderabad, under
my supervision and guidance in partial fulfilment of the
regulations governing the diplomate of National Board degree in
ANAESTHESIOLOGY.
DATE
PLACE
DR. S
PRASH
ANTH
REDDY
HOD
OF THE
DEPAR
TMENT
YOSHA
DA
HOSPI
TAL
SOMAJ
IGUDA

ENDORSEMENT BY THE H.O.D.

 This is to certify that the dissertation entitled “COMPARISON OF SURGICAL
PLETH INDEX —GUIDED ANALGESIA WITH CONVENTIONAL
ANALGESIA WITH DESFLURANE ANESTHESIA IN LAPAROSCOPIC
ABDOMINAL SURGERIES” is a bonafide work done by DR.
CHANDINI.KILLARI, under the guidance of DR.S S PRASHANTH REDDY, Head
of the department, Anaesthesiology, Yashoda super specialty hospital, Somajiguda,
Hyderabad.

Date: Seal and signature of the

H.O.D.

PLACE DR. S PRASHANTH

REDDY
Head of the department
Yashoda Hospital
Somajiguda.
Hyderabad
 ENDORSEMENT BY THE HEAD OF INSTITUTION

This is to certify that the dissertation entitled “COMPARISON OF SURGICAL PLETH INDEX
—GUIDED ANALGESIA WITH CONVENTIONAL ANALGESIA WITH DESFLURANE
ANESTHESIA IN LAPAROSCOPIC ABDOMINAL SURGERIES” is a bonafide work done by DR.
CHANDINI.KILLARI, under the guidance of DR.S PRASHANTH REDDY, Head of the department,
Anaesthesiology, Yashoda super specialty hospital, Somajiguda, Hyderabad. In a partial fulfillment of
regulations governing the diplomate of national board degree in ANAESTHESILOGY.
I have great pleasure in forwarding this dissertation to National Board of Examination, New Delhi.

DATE:
PLACE:
DR. BALARAJU, MD (GENERAL MEDICINE)
HEAD OF INSTITUTION
YASHODA SUPER SPECIALITY HOSPITAL
SOMAJIGUDA
HYDERABAD.
 COPYRIGHT

DECLARATION BY THE CANDIDATE

I hereby declare that the National Board of Examinations, New Delhi shall have the rights to preserve, use
and disseminate this dissertation in printed or electronic format for academic/research purpose.

Date: Dr. CHANDINI.KILLARI

Place: Hyderabad DNB RESIDENT
YASHODASUPERSPECIALITY HOSPITAL
HYDERABAD
 ACKNOWLEDGEMENT

I express my extreme pleasure in acknowledging the contributions of all who have been instrumental in
successful completion of my work.
First and foremost, I must thank Almighty God; my parents without his blessings no endeavour can start,
continue or complete. I take this opportunity to express my indebtedness & gratitude to my guide Dr. S
PRASHANTH REDDY (Professor & Head of Anaesthesiology and pain, Yashoda hospitals, Hyderabad)
for his exemplary guidance, support and constant encouragement throughout the period of the study.
I wish to express my sincere thanks to Dr. MANISH, Dr. LAVANYA, Dr. PRAMOD, DR. AKHILESH
& DR. TIRUPATHI for their valuable suggestions, kind cooperation and guidance in preparing this
dissertation.
I humbly thank all my patients who agreed to participate in this study without whom, this study would have
been impossible.
I would like to thank my family, friends, colleagues, my seniors and juniors for their moral support.

DR. CHANDINI KILLARI

 LIST OF ABBREVIATIONS USED

ASA American Society of Anesthesiologists

ANSS Autonomic Nervous System State

ACTH Adrenocorticotropic Hormone

ABG Arterial Blood Gas

BIS Bispectral Index

BP Blood Pressure

CVS Cardiovascular system

CNS Central Nervous System

CPT Cold Pressor Test

Ce Effect site Concentration

CPP Cerebral Perfusion Pressure

ETCO2 End Tidal Carbon dioxide

ECG Electrocardiogram

EEG Electroencephalogram

EMG Electromyogram

FRC Functional Residual Capacity

GA General Anesthesia

HBI Heart Beat interval

HR Heart Rate
x
HHI Head Holder Insertion

Hz Hertz

IAP Intra -abdominal Pressure

ICP Intracranial pressure

IV Intravenous

Kpa Kilo Pascal

LAP Laparoscopic

MAP Mean Arterial Pressure

MAC Minimum Alveolar Concentration

Min Minutes

N2O Nitrous Oxide

NIBP Noninvasive Blood Pressure

NMBA Neuromuscular Blocking Agents

NRS Numerical Rating Score

PNP Pneumoperitoneum

PONV Postoperative Nausea Vomiting

PPGA Photoplethysmography Amplitude

xi
PVR Pulmonary Vascular Resistance

PCWP Pulmonary Capillary wedge Pressure

GA General Anesthesia

SSI Surgical Stress Index

SPI Surgical Plethysmographic Index

SD Standard Deviation

SVR Systemic Vascular Resistance

SPO2 Arterial Oxygen Saturation

TIVA Total Intravenous Anesthesia

V/Q Ventilation-Perfusion

µg Microgram

xii
 LIST OF TABLES

Sl No. TABLE TITLE Page No

1 Age distribution between the groups

2 Gender distribution between the groups

3 ASA status between the groups

Duration of surgery and anesthesia, age, height, and weight

4 between the groups

Baseline HR changes in both the groups

5

6 Intraoperative HR changes in both the groups

Intraoperative MAP changes in both the groups

7

Intraoperative SPO2 changes in both the groups

8

Intraoperative ETCO2 changes in both the groups

9

Intraoperative MAC values between the groups

10

Intraoperative analgesic drug administration and both groups

11

xvi
 Postoperative pain score for 1hr in both the groups
12

Postoperative PONV score in both the groups

13

Total intraoperative and post operative fentanyl consumption in both

14 the groups

xvii
 LIST OF GRAPHS

Sl No. GRAPH TITLE Page No

1
Comparison of Age distribution between the groups

2
Comparison of Gender distribution between the groups

3 Comparison of ASA status between the groups

4 Comparison of intraoperative HR changes in both the groups

5 Comparison of Intraoperative MAP changes in both the groups

6 Comparison of Intraoperative SPO2 changes in between the groups

7 Comparison of Intraoperative ETCO2 in both the groups

8 Comparison of Intraoperative MAC values in both the groups

9 Comparison of Intraoperative analgesic drug administration in both

the groups

10 Comparison of postoperative pain score for 1hr between the groups

11 Comparison of total Intraoperative and postoperative fentanyl

consumption in both the groups

xviii
 LIST OF FIGURES

Sl. No. Figure Title Page No.

1 Photoplethysmographic wave form

2 Absorption spectra of oxy and deoxyhemoglobin

3 Monitor showing SPI value

4 SPI learning at the beginning and during the operation

5 Numerical rating scale

xx
 ABSTRACT

“COMPARISON OF SURGICAL PLETH INDEX –GUIDED ANALGESIA WITH

CONVENTIONAL ANALGESIA USING DESFLURANE ANESTHESIA IN
LAPAROSCOPIC SURGERIES-A RANDOMISED DOUBLE BLINDED
CONTROLLED TRIAL”

Background: The Surgical Pleth Index is a multivariate index derived noninvasively from
finger plethysmographic signal. It has to correlate with intensity of surgical stress. so, that we
can see benefits of SPI guided Anaesthesia using balanced Anaesthesia using a volatile
anesthetic desflurane and fentanyl the opioid.
Methodology: After obtaining institutional ethical clearance and patient informed consent;
Sample size of 100 Patients with ASA I-II posted for laparoscopic surgeries under GA were
randomly allocated to the SPI & conventional analgesia group using randomization each
group containing 50 each.
In SPI group, SPI value >50; In conventional group, rise in HR, BP >20% above baseline
were the criteria for fentanyl administration. Fentanyl 0.5 µg/kg is administered in each group
for an event persisted for 5 min. Primary objective was to determine amount of intraoperative
fentanyl consumption, secondary objectives were intraoperative hemodynamic stability,
postoperative pain & PONV score for 1 hr. Pearson test used for correlation analysis.

Results: Total intraoperative fentanyl consumption was lower in SPI group than in the
conventional group but it was not statistically significant and the hemodynamic stability is
more in SPI group than in conventional group.

Conclusions: SPI guided analgesia resulted in lower intraoperative fentanyl consumption and
more stable hemodynamics. Postoperative pain score and rescue fentanyl administration and
PONV scores were comparable in both the groups.

xiii
 INTRODUCTION

General anesthesia is the combination of hypnosis, anti-nociception, muscle

relaxation, loss of consciousness. The monitoring of hypnosis and immobility is easy
clinically, but for anti-nociception a valid monitoring is missing. Excessive and
insufficient depth of anesthesia during general anesthesia is affecting patient
outcome .so the adequate anesthesia required for the patient to get better outcome. To
achieve the adequate analgesia (antinociception) blunting the intraoperative stress
response, most notably hemodynamic instability, it is crucial to use an ideal variable
for assessing the stress level. The balance of nociception- antinociception 2, during
general Anaesthesia is required. An ideal (continuous, noninvasive, accurate) variable,
is still missing which may be used for guiding administration of analgesics to
attenuate the stress response. Traditionally, clinical signs, which have been proved to
be unreliable demonstrating low specificity, like somatic (movement) or autonomic
(tachycardia, hypertension, sweating, and tearing) responses are used to evaluate
whether analgesia is adequate.
Monitoring of the nociceptive response to stressful stimuli remains a challenge during
general Anaesthesia. Direct, clinically relevant, specific indicators of the nociception
during general Anaesthesia do not exist.
Adequate hypnosis and analgesia are essential to maintaining an adequate anesthetic
depth. There are methods like bispectral index and entropy to monitor depth of
Anaesthesia but adequate monitor for analgesia is still missing and we still depend on
conventional methods like monitoring BP and HR.
SPI is newly developed monitor which guides proper analgesia during GA which
derived from pulse plethysmographic amplitude and heart rate from pulse oximeter.
Several studies says that SPI more reliably monitors the nociception– antinociception
balance than other parameters like HR and Entropy.
Nociception during general Anaesthesia can elicit significant autonomic, hormonal,
and metabolic changes. Marked changes in heart rate, blood pressure, or patient
movement during Anaesthesia are considered signs of inadequate Anaesthesia. several
opioids are used during anesthesia to prevent the changes. This can lead to post
operative respiratory depression.
Surgical Pleth Index is a multivariate index derived noninvasively from finger plethysmographic
signal. It has been demonstrated to correlate with surgical stress intensity. In the setting of total
intravenous anesthesia (TIVA) other studies had shown the beneficial effects of SPI guided
analgesia in terms of remifentanil consumption, hemodynamic stability and incidence of unwanted
events. Therefore, we examined whether these beneficial effects of SPI guided anesthesia can be
transferred to a setting of balanced anesthesia using a volatile anesthetic desflurane and the opioid
fentanyl.
 OBJECTIVES

Primary objective

To determine the amount of intraoperative fentanyl consumption

Secondary objectives: includes,

i) Hemodynamic stability measured by following events during anesthesia:

hypotension, hypertension, tachycardia, bradycardia.
ii) Postoperative naus ea v om it in g events determined by Postoperative Nausea
Vomiting (PONV) score.
iii) Postoperative pain determined by Numerical Rating Score (NRS).
 REVIEW OF LITERATURE

Huiku et al. in 2007, a study included 60+12 females scheduled for gynecological or
breast surgery ASA I or II under GA were included in the development and validation
data sets, respectively. All patients were premedicated with oral diazepam, were
anaesthetized with propofol and remifentanil, and muscle relaxation was achieved
with bolus doses of rocuronium or cisatracurium. Propofol and remifentanil were
administered as target control infusions (TCI) (Fresenius Orchestra Primeaw, France).
For propofol, the pharmacokinetic model of Schnider and colleagues and for
remifentanil, the pharmacokinetic model of Minto and colleagues were used. Propofol
TCI was adjusted to maintain state entropy(SE)level between 35 and 60, the target
being 50.
During general Anaesthesia, SSI correlated positively with the estimated nociceptive
stimulus (median Spearman correlation coefficient=0.56, P< 0.0001) and negatively
with the antinociceptive medication (median Spearman correlation coefficient, r = -
0.21, P< 0.0001). Median Spearman correlation with the TSS (Total Surgical Stress)
estimate was 0.48(P< 0.0001). (All Wilcoxon signed rank.)
SSI was high when noxious stimulation was high and the remifentanil concentration
was inadequate; SSI was low when the remifentanil concentration was high or the
stimulation was low. And they concluded that SSI reacts to surgical nociceptive
stimuli and analgesic drug concentration changes during Propofol – remifentanil
Anaesthesia.

Study conducted by Struys M et al. in 2007 with 40 ASA 1 and II patients, aged 18–
65 yr, undergoing urological or gynecological surgery. Patients were allocated to one
of the 4 groups to receive a remifentanil step-up/-down effect-compartment target-
controlled infusion (Ceremi) of 0, 2, 6, 2, 0 ng /ml, or 6, 2, 0, 2, 6 ng/ ml, and an
effect-compartment target-controlled propofol infusion (Ceprop). At each steady-state
Ceremi, maximum change in SSI, RE, PPGA, and HR after a noxious stimulus was
compared with the baseline value.
Static and dynamic values of SSI correlated to Ceremi better than SE, RE, HR, and
PPGA. SSI was independent of Ceprop, in contrast to SE and RE. The PK for Ceremi
both before and during a noxious stimulus was better with SSI. They concluded that
SSI appear to be a better measure of nociception - antinociception balance than SE
(State Entropy), RE (Response Entropy), HR or PPGA (Photoplethysmographic
waveform amplitude).
Ahonen J et al. in 2007 study included 30 women undergoing gynecological
laparoscopy were assigned randomly to receive esmolol (n=15) or remifentanil
(n=15). Anaesthesia was induced with propofol and fentanyl and maintained with
desflurane and nitrous oxide 50% in oxygen to keep SE at 50. The infusion of esmolol
or remifentanil was started before laparoscopy and adjusted to keep the systolic blood
pressure at -20 to+10% from the preoperative value.

Results shown that, during the fentanyl phase, before surgery, both groups behaved
similarly, with an increase in SSI after intubation. In the patients receiving esmolol,
the SSI reacted to the initial incision (P< 0.05), and remained high after trocar
insertion (P< 0.05). In patients receiving remifentanil, it did not react to the initial
incision, but increased after trocar insertion (P< 0.05), and it remained lower both
after incision (P< 0.05) and after trocar insertion (P< 0.05). They concluded that SSI
was higher in patients receiving esmolol the index seems to reflect the surgical stress
and may help to guide the use of opioids during general Anaesthesia.

Study conducted in 2010 by Chen et al. included 80 patients scheduled for elective
ear–nose–throat surgery was randomized into two groups, SSI-guided analgesia group
(SSI group) and standard practice analgesia group (control group). In both groups,
anesthesia was maintained with a propofol target-controlled infusion and adjusted
stepwise by 0.5 µg/ml to keep bispectral index values between 40 and 60. In the SSI
group, the predicted effect-site concentration of remifentanil was adjusted stepwise by
1 ng/ml to keep SSI values between 20 and 50, whereas in the control group,
predicted effect-site concentration of remifentanil was adjusted according to
traditional inadequate analgesia criteria.

Anesthetics consumption, recovery times, and incidence of unwanted events were

recorded. Results showed that SSI guided Anaesthesia resulted in lower remifentanyl
consumption than in the control group (mean±SD,9.5±3.8µg/kg/hr.
Vs12.3±5.2µg/kg/hr.; P<0.05), The number of unwanted events was less in the SSI
group than in the control group (P<0.01). Recovery times were comparable between
groups. And concluded that SSI-guided anesthesia resulted in lower remifentanil
consumption, more stable hemodynamics, and a lower incidence of unwanted events.
A study by Bergmann et al. in 2013.A total of 170 outpatients given TIVA with
propofol and remifentanil. The patients were randomized to have the remifentanil
dose either adjusted according to the SPI (SPI group) or to clinical parameters (control
group). The propofol dose was adjusted according to entropy in both groups. The
consumption of anesthetic drugs, recovery times, and complications were compared.
The mean (SD) remifentanil and propofol infusion rates in SPI and control groups
were 0.06(0.04) vs 0.08(0.05) µg/kg/min and 6.0(2.1) vs 7.5(2.2) mg/kg/hr.
respectively (both P<0.05). Concluded that, adjusting the remifentanil dosage
according to SPI in outpatient Anaesthesia reduced the consumption of both
remifentanil and propofol and resulted in faster recovery.

A randomized double blinded control trial conducted by Park JH et al. in 2015, 45

children undergoing elective adenotonsillectomy were randomly allocated to SPI-
guided group (SPI-guided analgesia group, n = 21) or control group (conventional
analgesia group, n = 24). Anesthesia was maintained with sevoflurane 2 to 3 vol% in
50% nitrous oxide and oxygen to achieve state entropy between 40 and 60.
Intraoperative fentanyl 0.5 µg/kg was administered for the first event persisting 3 min
and subsequent events persisting 5 min. An event was defined as an SPI over 50 (SPI-
guided group) or a blood pressure or heart rate 20% above the baseline (control
group). The primary outcome was intraoperative fentanyl requirement. Secondary
outcomes included intraoperative sevoflurane consumption, postoperative emergence
agitation and pain score, and postoperative rescue analgesic requirements.
Result shown that intraoperative fentanyl requirement was lower in SPI guided group
than in control group (0.43 ± 0.53 vs 1.73 ± 0.59 µg / kg; p < 0.001). Intraoperative
sevoflurane consumption was similar. Postoperative pain score and rescue fentanyl
consumption were higher in SPI guided group. Concluded that as currently
constructed, SPI does not appear to be valid in children. This may be due to both
differences in blood vessel distensibility and baseline increased heart rates in children
versus adults.
Recently in 2016, a study by Harju J et al. in 30 children <2 yr., planned for elective
open inguinal hernia repair or open correction of undescended testicle, were recruited.
The children were randomized into two groups; the saline group received ultrasound-
guided saline injection in the ilioinguinal and iliohypogastric nerve region before
surgery and ropivacaine after surgery, whereas the block group received the injections
in the opposite order. The SPI was recorded blinded and was analyzed at the time
points of intubation, incision, and when signs of inadequate anti-nociception were
observed. Results shown that there was a significant increase in the SPI after
intubation (P=0.019) and after incision in the saline group (P=0.048), but not at the
time of surgical incision in the block group(P=0.177). An increase in the SPI was also
seen at times of clinically apparent inadequate anti-nociception(P=0.008). The
between-patient variability of the SPI was large.
Concluded that the SPI is reactive in small children after intubation and after surgical
stimuli, but the reactivity of the SPI is rather small, and there is marked inter-
individual variability in reactions. The reactivity is blunted by the use of ilioinguinal
and iliohypogastric nerve block. Results shown that The SSI was higher in patients
undergoing spinal Anaesthesia compared with GA and baseline. During spinal
Anaesthesia with sedation, it was comparable with the baseline level. In comparison
with baseline, SSI in the recovery room was higher in patients after GA but not after
spinal Anaesthesia or after spinal Anaesthesia with sedation. Changes of the SSI were
not reflected by changes of hemodynamic variables. They concluded that in fully
awake patients under spinal Anaesthesia, the SSI does not reflect the nociception–
antinociception balance. This may be due to the influence of mental stress on the
sympathetic nervous system. Even light sedation attenuates these influences

Colombo R et al. in 2014, A randomized, cross-over group study including 42 adult

patients undergoing scheduled laparoscopic abdominal surgery.
ECG, NIBP and SPI were recorded during balanced general Anaesthesia with inhaled
sevoflurane and intravenous remifentanil. After pneumoperitoneum induction, the
remifentanil infusion rate was set to obtain two different levels of SPI (>50, HI-SPI,
and <50, LO-SPI) for each patient.
39 patients were included in the final analysis. During LO-SPI, HR and systolic and
mean blood pressures were significantly lower than HI-SPI. The median low
frequency/high frequency ratio was reduced during LO-SPI [1.29 interquartile range
(IQR) 0.66 to 2.05) vs. 2.36 (1.30 to 3.62), P=0.008]. The sensitivity analysis revealed
a significant correlation between SPI changes and changes of all ANS indices, arterial
pressure and HR, with a slightly better correlation for low frequency/high frequency
(Spearman q=0.70, IQR 0.484 to 0.834, P<0.001).
They concluded that, in the context of a balanced general Anaesthesia in healthy
patients undergoing laparoscopic abdominal surgery, ANS modulation seems to
correlate with changes in SPI.
Gruenewald M et al. in 2009, a study involving 24 patients ASA I or II, aged
between 18 and 65 yr., undergoing elective gynecological laparoscopy were enrolled.
Patients received incremental or decremental doses of 0, 2, and 4 ng/ml remifentanil
effect-site concentration (Ceremi) during 0.7 MAC sevoflurane. Painful tetanic
stimulation was applied at least 5 min after changing Ceremi. SSI, heart rate (HR),
response entropy (RE), state entropy (SE), RE–SE difference, and bispectral index
(BIS) were obtained in each patient before and after stimulation. Further prediction of
an author-defined response to painful stimulus was analyzed. They concluded that
The SSI response to tetanic stimulation was dependent on the remifentanil
concentration.

A study by Ledowski T et al. in 2016 involving 70 patients undergoing non-

emergency surgery were enrolled. Data relating to SPI, heart rate, mean arterial
pressure, and state entropy were recorded every 10 s for the last 10 min of surgery.
Subsequently, recordings continued during the phase of arousal. After recovery room
admission, pain scores (numerical rating scale 0–10) were obtained every 3 min for 15
min.
They concluded that Surgical pleth index values are predictive of postoperative pain
only if obtained before patient arousal. In contrast to previous studies, a relatively low
SPI, >30, appears to predict pain with a high positive predictive value and may
therefore be suggested for future studies of SPI-guided Anaesthesia.
Won YJ, Lim BG, Yeo GE, et al. The effect of nicardipine on SPI during
thyroidectomy under general Anaesthesia a prospective double blind randomized
controlled trial. Medicine (Baltimore) 2017:
Mobini A., Mehra P., Chigurupati R. Concluded the pain and post operative analgesic
requirement in women and younger patients in immediate post operative period after
orthognathic surgeries Oral Maxillofac Surg.2018:76:2285-2295.

A study by Chen X et al. in 2012 involving 80 patients undergoing elective ear-

nose-throat surgery were enrolled in the present study to investigate the relationship
between surgical pleth index (SPI) and stress hormones (ACTH, cortisol, epinephrine,
norepinephrine) during general Anaesthesia which was induced and maintained with
propofol and remifentanil using a target-controlled infusion. The study concluded that
the SPI had moderate correlation to the stress hormones during general Anaesthesia,
but no correlation during consciousness. Furthermore, SPI values were able to predict
ACTH values with high sensitivity and specificity.
BASIC SCIENCES AND PHARMACOLOGY
LAPAROSCOPIC SURGERIES
The main aim of anesthetist during lap surgeries is to maintain hemodynamic stability and
prevent unwanted events like tachycardia, hypertention and hypotention. these unwanted
events are more with pneumoperitoneum i.e., CO2 insufflation.Laparoscopic surgeries are
insufflation of co2 in to abdominal cavity known as pneumoperitoneum i.e., using CO2
insufflator which supply gas in to abdomen till IAP required for surgery is reached. The
pressure varies from 0-30mm hg. Gas flow ranges from 0-9.9.These changes include
increase in SVR and PVR which increases MAP, reduction in CO and stroke volume and
this is both humoral and mechanically mediated mechanism

PHYSIOLOGY OF LAPAROSCOPY
A) Physiological effect of pneumoperitoneum
B) Physiological effects of CO2 absorption
C) Effects of gas insufflation.

PHYSIOLOGICAL EFFECTS OF PNEUMOPERITONEUM

Cardiovascular System; Increased IAP initially led to increase in venous return and cardiac
output.further IAP increase cause compression of inferior venacava causing reduction in venous return
and cardiac output. There is increase in systemic vascular resistance due to increase in catecholamine,
nor epinephrine and epinephrine release. this change is greater than CO reduction leading to CO
increase. Increase in BP, HR, SVR lead to increase in cardiac workload and myocardial ischemia.
Furthermore, increase in IAP leads to decrease in CO lead to fall in BP.

RESPIRATORY SYSTEM:GA and supine position lead to decrease in FRC . FRC less than closing
volume, lead to atelectasis, airway collapse, V/Q mismatch, hypoxia and hypercarbia. Increase in
airway resistance and decrease in compliance potentiates risk of barotrauma with PPV.

Renal System Marked increased IAP reduces renal function and urine output lead to increase in renal
vascular resistance and reduction in GFR.
Gastrointestinal System:Increased IAP cause regurgitation of gastric contents which can lead to risk of
pulmonary aspiration.

C.PHYSIOLOGICAL EFFECTS OF CARBON DIOXIDE ABSORPTION

CO2 is most commonly used gas for abdominal insufflations and it is non-toxic colorless and non-
inflammable gas. Because of its solubility it is readily observed from peritoneum and increase in
PaCO2 so it effects more on cardiac system causing increase in heart rate decrease in contractility of
heart and reduction in diastolic filling causing imbalance in myocardial oxygen supply to demand ratio
can lead to myocardial ischemia.
D.EFFECTS OF GAS INSUFFLATION
Arrhythmia stretching of peritoneum lead to vagal stimulation can cause nodial rythum, bradycardia
and asystole. Subcutaneous emphysema, pneumomediastinum, and pneumothorax
Venous gas embolism: It can lead to Hypotention, desaturation and mill wheel murmur .
 PHOTOPLETHYSMOGRAPHY
Photoplethysmography (PPG) is noninvasive optical technique widely used for studying
ana monitoring the pulsations associated with changes in blood volume in a peripheral
vascular bed.PPG is well known for its application in pulse oximetry, used for continuous
and noninvasive measurement of SpO2.

PPG utilizes the absorptivity of light resulting from the variations in the physiological
properties of tissue components during cardiac cycle. Cardiac cycle consists of systole
and diastole. During systole, blood pumped out of the heart and rushes the blood
throughout the body, including all pheripheral tissues. This increases the blood volume
results in increase in absorbance of light in tissue compared to diastole. This relative
change in light absorbance gives rise to PPG pulsatile waveform synchronous with each
heartbeat.

FIGURE-1: Photoplethysmographic waveform

Clinical applications:
PPG used for monitoring saturation, HR, BP, CO, respiration, vascular assessment and autonomic
function.
PULSE OXIMETRY
Measures capillary O2 saturation i.e., amount of oxygen in blood. Ratio of HbO2 /Total Hb conc in
blood. Both saturation and pulse rate are measured by this. PRINCIPLE: O2 Hb absorbs more infrared
light (wave length is 850-1000nm) and allows more red light(600-700nm) to pass through. DEO2 Hb
absorbs more red light and allows more infrared light to pass through. Ratio between amplitude of their
wavelength gives O2 saturation by pulse oximeter. This is based on BEER-LAMBERTLAW.

FIGURE-2: Absorption spectra of oxy and deoxyhemoglobin

BEER’S law states intensity of light decreases with increase in concentration of substance.
Lambert’s law states it decrease with distance travelled through the substance.

Limitations
Pulse oximeters do not require user calibration. It may give false readings. The pulse
oximeter will work properly only if it is able to detect a modulation in transmitted light. If
perfusion is decreased and pulse amplitude is small, the signal will be decreased. Poor
peripheral perfusion because of hypothermia or hypotension is the principal cause for
failure to obtain a signal.
 Reliable with systolic blood pressure readings greater than 80 mm Hg. Hypotension, low
cardiac output, vasoconstriction, vasoactive drugs (noradrenaline and adrenaline), and
hypothermia all reduce tissue blood flow. Lowered perfusion reduces the signal strength.
Improperly placed sensors, shivering, seizures, or parkinsonian tremors can cause
movements, creating an inaccurate reading.
readings are inaccurate in the presence of abnormal hemoglobin levels. Thus, carbon
monoxide poisoning will result in an erroneous SpO 2 reading as a result of
carboxyhemoglobin. Smokers will often have artificially high readings after smoking
because cigarette smoke contains carbon monoxide. The presence of methemoglobin will
also give an unreliable oximeter reading.
High-intensity lighting, typically fluorescent lights, may lead to false readings. This can be
corrected by turning off the bright light. Nail polish and artificial fingernails generally do
not interfere with oximetry readings, except in the case of black, blue, or green nail polish.

Interpretation
Normal arterial oxygen saturation is considered to range between 97% and 100%. So.
Readings of 90% or less may need supplemental oxygen. values below 70% obtained by
pulse oximetry are unreliable. ABGs should be performed for confirmation of hypoxia.
Even when the pulse oximeter reads the SpO2 as normal, the patient could have undetected
carbon dioxide retention. Therefore, don’t rely on the information from pulse oximeter
alone in the assessment and diagnosis of hypoxemia.

Pulse Oximetry
Oxygenation
SpO2(%) PaO2(mm of Hg) Status

95–100 80–100 Normal

91–94 60–80 Mild hypoxia
Moderate
86–90 50–60
hypoxia
Severe
Less than 85 Less than 50
hypoxia
SPI:
The surgical pleth index (SPI) uses pulse plethysmography (HBI) and photoplethysmography (PPG)
from pulse oximetry monitoring, it is an index of the nociception–anti-nociception balance. Correlates
with surgical stimuli and dosage of analgesic and predicts the effect of pain stimuli and analgesic
therapy with greater certainty than other clinical parameters.
SPI, also used to monitor the patient’s responses to surgical stimuli and analgesic medications during
GA. Increase in SPI reflects the increased sympathetic activity as with painful stimuli.
SPI monitoring is based on analyses the photoplethysmographic amplitude and the pulse interval, and
then combines these two parameters to create a single digit, the Surgical Pleth Index.

FIGURE-3: Monitor showing the SPI value

Pain increases sympathetic response of ANS.Surgical stimulus reduced by analgesics.

Inadequate analgesia increases HR and vasoconstriction.
SPI=100-(0.7PPGAnorm+0.3HBInorm) where PPGA norm is normalized
plethysmographic pulse wave amplitude and HBI norm is normalized heart rate interval.
SSI is a simple numerical value ranging from 0(very low stress) to 100 (very high
stress).50 is mean stress.SSI now renamed as SPI. SSI was developed during propofol–
remifentanil Anaesthesia in gynecological patients.
CLINICAL USE: SPI used to help assess acute pain and autonomic reactions during
GA.SPI value increase with surgical response and decrease once the surgical response
decreased.
SPI is affected by pacemaker and with use of Atropine. Factors affecting hemodynamic
stability also affects SPI.Its an optional software
FIGURE-4: SPI learning at the beginning and during the operation
FENTANYL

Potency:
Fentanyl is 1000 times more potent than Meperidine. 50 –100 times more potent than Morphine.

Mode of action:
Fentanyl is a highly selective µ receptor agonist is responsible for analgesic properties.

Pharmacokinetics and Pharmacodynamics:

Fentanyl IV has a rapid onset and shorter duration of action than Morphine. The effect site
equilibration time between blood and the brain is 6.4 minutes and greater lipid solubility, which
facilitates its passage across blood-brain barrier. 75% of the initial dose undergoes first pass
pulmonary uptake. Effective analgesic dose 1 and 3ng/ml, while concentrations of 1.5 to 3ng/ml.

Metabolism:
Fentanyl avidly binds to alpha-1-acid glycoprotein and is also bound to albumin. Cytochrome P–
4503A4 plays the predominant role in Fentanyl metabolism.
Clearance is decreased in patients with hepatic involvement.

Analgesic potency:

• It is 29 times more potent than Morphine.

• Therapeutic index – 323 and pKa – 8.4.

Effects:
CVS.
 Doses of 7mcg/kg at induction decreases heart rate
 At 10mcg/kg myocardial contractility is reduced by 50%.20 to 25mcg/kg
decreases heart rate, MAP, SVR, PVR and PCWP by15% in patients with
CAD.
RS:
• Fentanyl at 1 to 2 mcg/kg decreases RR and increase TV.> 3mcg/kg it decreases both RR and
TV.
• Chest wall rigidity (“Wooden – chest” phenomenon) due to its effect on µ receptors.
Controlled by the early use of muscle relaxants.

CNS: It is a CNS depressant.

GIT: It causes nausea, vomiting and decreases GI motility.
GU: Retention of urine.
 Clearance is decreased in patients with hepatic involvement.

Relationship between Fentanyl Plasma Concentration and Effect59

Plasma Fentanyl
concentration
(ng/ml) Pharmacological effect

>1 Slight analgesia, minimal ventilatory depression

1-3 Analgesia; 50% decrease in the ventilator response to carbon dioxide
4-10 Analgesia for surgery if combined with nitrous Oxide

>20 Unconsciousness, satisfactory anesthesia if used as sole

Agent

DESFLURANE
• Fluorinated methyl ethyl ether
• B/G PC: 0.45 – rapid induction and recovery
• MAC: 6.6 – low potency
• Boiling point: 19 * C – extremely volatile
• SVP: 666 mmHg
• Latent heat of vaporisation – HIGH
• special vaporizer. - TEC 6 electrically powered
• Most pungent - coughing, salivation, breath holding, and laryngospasm.
• Desflurane has the lowest blood: gas solubility of the potent VA
• Desiccated soda lime – produces CO
• Metabolism: Minimal < 0.01%
No fluorides – AOC in renal patients / obese pts / long duration surgery / old pts
• With MAC < 6%: No coronary steal syndrome – can be used in all cardiac patients including MI
• With MAC > 6 %: + SNS – Inc in HR & BP, hence AOC in SHOCK

Effects on the body:

CNS
 dose-dependent depression of CNS.
 produces vasodilatation of the cerebral vessels, increases cerebral blood flow and can increase
intracranial pressure when used in excess of 1 MAC.

CVS
 cardio stable agent but causes tachycardia (more than isoflurane at equipotent concentrations).
 It maintains cardiac output.
• does not sensitize the myocardium to catecholamines or predispose to arrhythmias. Desiccated soda
lime – produces CO
• With MAC < 6%: No coronary steal syndrome – can be used in all cardiac patients including MI
• With MAC > 6 %: + SNS – Inc in HR & BP, hence AOC in SHOCK
MONITORING DEVICES FOR MEASURING THE DEPTH OF ANAESTHESIA
Adequate depth of Anaesthesia during surgical procedures is required. While deep level of Anaesthesia,
lead to cardiovascular depression and prolonged awakening times is of minor clinical interest, the opposite
- light Anaesthesia – is more difficult to detect and frightening. So, depth of Anaesthesia is fundamental to
anesthetic practice. With the absence of movement on incision it was safe to assume that the patient was
not aware, however with the use of muscle relaxants it is necessary to be use potent opioids, IV and
inhalational agents and regional nerve blocks to measure depth of Anaesthesia.

Classification of methods of monitoring depth of Anaesthesia

Clinical techniques and conventional monitoring

A. Clinical sign
B. Skin conductance
C. Isolated forearm technique
D. Spontaneous surface electromyogram (SEMG)
E. Lower oesophageal contractility
F. Heart rate variability

A. Brain electrical activity monitoring

1. Spontaneous EEG activity monitors.

(i) EEG
(ii) Compressed spectral analysis
(iii) EEG with compressed spectral analysis
(iv) Cerebral function monitor (CFM)
(v) Cerebral function analysis monitor (CFAM)
(vi) Bispectral index
(vii) Entropy
(viii) Narcotrend®
(ix) Patient state analyzer
(x) SNAP index
(xi) Cerebral state monitor/Cerebral state index

2. Evoked brain electrical activity monitors.

(i) Somatosensory evoked potential (SSEP)

(ii) Visual evoked potential (VEP)
(iii) Auditory evoked potential (AEP)
 METHODOLOGY

A study entitled, comparison of surgical pleth index –guided analgesia with conventional analgesia
during desflurane anesthesia in abdominal surgeries-a randomized controlled trial”, will be conducted
in Yashoda Super specialty hospital, Somajiguda, Hyderabad, Telangana. The study will conduct after
obtaining institutional ethical clearance and written informed consent from all the patients.

INCLUSION CRITERIA:
A. Patients aged between 20 to 65yrs.
B. ASA (American Society of Anesthesiologist) grade I andII.
C. Written informed consent.

EXCLUSION CRITERIA:
A. Any lung, liver or renal disease.
B. History of peptic ulcer disease
C. Body-mass-index 30 or more
D. History of cardiac arrhythmia
E. Presence of any neuromuscular OR neurologic disease
F. Use of CNS active medication oral alcohol or drug abuse
G. Those who are unable to give consent
H. High BP or use of beta blockers.
I. Pregency
J. Those who are unable to give the consent
 STUDY DESIGN: A Randomized Double Blinded Controlled trial

STUDY PERIOD: May 2021 to April 2022

SAMPLE SIZE: 100, Calculated using open epi software
version 2.3.1 At 95% confidence level, 80 % power of study
According to study conducted by Xin Zhong Chen

mean±SD analgesic consumption by SSI group was

9.5±3.8 mean±SD analgesic consumption by
conventional group was 12±5.2 sample size calculated
was 42-45in each group
ie,45 in SSI group and 45 in conventional group

Formula used:2(za+zþ)2o2

d2

Total 100 patients were considered.

ie,50 in SSI group and 50 in conventional group.

Materials: GE Aisys cs2 machine with SPI software.

SAMPLING: Total 100 patients has been randomly allocated to the SPI-guided
analgesia group (SPI- guided group) or the conventional analgesia group (control
group),50 in each group .

BLINDING: Random numbers from a computer-generated table will obtained and kept
in opaque sealed envelopes which were opened by an independent anesthesiologist
not involved in the study.
METHOD:

Patients were randomly be allocated to the SPI-guided analgesia group (SPI guided group)
or the conventional analgesia group (control group) based on the criteria of analgesic
administration. Randomization done using computer generated randomization table.

Monitor connected to all the patients which include. Noninvasive BP monitoring,

electrocardiography, pulse oximetry, end-tidal carbon dioxide, SPI monitoring (Care
station; GE Healthcare,) was performed, and preanesthetic MAP and HR will be
recorded for all patients.

In the operating room, induction and maintenance of anesthesia and analgesic

administration was performed by other independent anesthesiologists not involved in
the study.

General anesthesia was induced with intravenous propofol 2 mg/kg, intravenous

Atracurium
0.5 mg/kg, and mask ventilation with desflurane 5-6vol% and oxygen 6 l/min for 2
min, followed by intubation. Mechanical ventilation maintained at a tidal volume of 6
to 8 ml/kg, and ventilation frequency will be adjusted to maintain an end-tidal carbon
dioxide between 25 to 35 mmHg.

Anaesthesia maintained and continuously adjusted with desflurane with MAC0.7to0.8

with 50 % air and 50% O2.

*With desflurane 6% MAC 0.7 will be maintained. The analgesic administration in each
group will be given accordingly in which an SPI value over 50 and a blood pressure or
heart rate increase 20% above baseline value was setas equivalent indicators of light
analgesia, and if event occurred, then fentanyl 0.5 μg/kg administered IV for the first
event persisted 3 min; the same dose was repeated for any additional events persisted
Atracurium top up of 0.1mg/kg was administered for every 20-30mints for maintenance of
Anaesthesia and muscle relaxation.

In SPI-guided group, the SPI target range was 20 to 50; an event was defined as an SPI
increase to greater than 50. In control group, an event was defined as an intra -operative
MAP or HR increase to 20% or more of the pre-anesthetic baseline value .

MAP and HR will be recorded every 5min, and in SPI-guided group, the SPI value was
documented at the same interval.
Desflurane discontinued at surgical conclusion, and air and oxygen of 6 l/min each was
provided. When spontaneous ventilation recovered patients were received IV
neostigmine 0.05 mg/kg and glycopyrrolate 0.08 mg/kg to reverse muscle relaxation,
and the endotracheal tube will be removed after spontaneous ventilation and muscular
strength sufficiently recovered.
In the recovery room, PONV and Pain were scored by the investigator blinded to the patient’s
assignment.

The pain score was determined using the Numerical rating Score (NRS) which comprises 0-10 scale
(0-no pain to 10-worst imaginable pain). PONV was rated according to PONV score. The scores were
measured during the stay in the recovery room.
Patients with an NRS score 4 or greater was administered fentanyl 0.25 μg/kg, and patients were
assessed every 15 min till first hour.
Adverse events, including respiratory depression (oxygen saturation <95%) and nausea or
vomiting, were recorded. In patients experienced respiratory depression, we applied an oxygen
mask. Nausea or vomiting was treated with IV ondansetron 0.15 mg/kg.

The SPI was calculated using methodology described in a report by Huiku et al.
SPI values range from 0 to 100, with higher scores indicating higher stress levels, and calculated as
follows

The heart beat interval (HBI) and PPGA were determined first from photoplethysmography
through pulse oximetry. Of these, PPGA was measured as the distance from the pulse baseline
to pulse maximum in the plethysmographic signal. It means the percentage from the light that
passes the tissue at a certain heart rhythm and it is presented as an arbitrary unit using integer
arithmetic so that the reading of 100 is 1% of the PPGA.
Then, the HBI and PPGA were normalized (HBInorm; PPGAnorm) to a
corresponding data distribution from a large group of adult patients using a histogram transformation.
Finally, the SPI was calculated using the following equation:
SPI =100-(0.33 HBInorm +0.67x PPGAnorm)

APPENDIX 1: PONV was assessed by 4 POINT

SCALE

 mild nausea
 moderate nausea
 severe nausea with retching
 vomiting
PAIN SCORE:
STATISTICAL ANALYSIS

continuous data was expressed as means (SD); categorical data was expressed as no of occurrence.
Comparison analysis was performed using t -test for continuous variables and chi square or Fisher exact test
for non-continuous variables. Correlation analysis was performed using the Pearson and test. P value less than
0.05 was considered significant in case of intraoperative fentanyl consumption. Other parameters like
postoperative nausea and vomiting, hemodynamic stability is more or less equal in both the groups depends on
patient age comorbidities like HTN, DM etc., and ASA status.
SAMPLE SIZE: 100, Calculated using open epi software version 2.3.1 At

95% confidence level, 80 % power of study

According to study conducted by Xinzhuang Chen

mean’s analgesic consumption by SSI group was 9.5±3.8 mean±SD

analgesic consumption by conventional group was 12±5.2 sample

size calculated was 42-45in each group

ie,45 in SSI group and 45 in conventional group

Formula used:2(za+zþ)2o2

d2
Total 100 patients were considered.

ie,50 in SSI group and 50 in conventional group.

 RESULTS

Age group SPI Percentage Conventional Percentage

10-19 years 0 0 1 2
20-29 years 5 10 5 10
30-39 years 8 16 8 16
40-49 years 16 32 15 30
50-59 years 17 34 13 26
60-69 years 4 8 8 16
Grand Total 50 100 50 100

Age distribution
18

16

14

12
SPI
10 Conventional
8

0
10-19 years 20-29 years 30-39 years 40-49 years 50-59 years 60-69 years
 Page 55

Gender SPI Percentage Conventional Percentage

Female 27 54 30 60
Male 23 46 20 40
Grand Total 50 100 50 100

Gender distribution
35

30

25
SPI
20 Conventional

15

10

0
Female Male
ASA grade SPI Percentage Conventional Percentage
1 25 50 26 52
2 25 50 24 48
Grand Total 50 100 50 100

ASA grade
26.5

26

25.5

SPI
25
Conventional

24.5

24

23.5

23
1 2
Parameter Group I Group II P value
Age in years 46.06 ±10.95 45.6 ±12.54 0.84
Height in cms 162.36 ±8.07 161.74 ±8.31 0.7
Weight in kgs 73.26 ±12.36 67.4 ±11.28 0.01
Duration of surgery in min 38.6 ±11.34 35.6 ±7.46 0.12
Duration of anesthesia in min 47.5 ±11.74 45 ±8.01 0.21

Baseline Parameter Group I Group II P value

SPO2 97.6±0.728 97.88±0.59 0.03
Heart rate 72.04±11.77 73.8±11.29 0.44
SBP 132.06±19.7 122.6±20.15 0.01
DBP 79.54±8.25 76±7.28 0.02
MAP 104.54±17.34 87.14±21.23 0.00001

Intra operative Heart Rate:

Time Group I Group II P value
5 min 68.24±12.49 71±10.98 0.24
10 min 66.9±12.44 71.1±14.64 0.12
15 min 65.36±10.51 69.49±11.39 0.06
20 min 67.04±11.29 71.96±12.81 0.04
25 min 68.86±12.22 71.46±12.48 0.29
30 min 67.94±9.46 71.62±13.01 0.108
35 min 67±7.49 70.73±14.04 0.1
40 min 67.8±10.48 75.18±9.89 0.0004
45 min 67.93±11.05 75±10.66 0.001
50 min 63.37±11.55 77.4±5.03 <0.0000001
55 min 63.42±6.07 75.5±6.82 <0.0000001
60 min 68±9.46 76±8.66 <0.0000001

Intra operative HR
90
80
70
60
50
40
30
20
10
0
5 min 10 min 15 min 20 min 25 min 30 min 35 min 40 min 45 min 50 min 55 min 60 min

Group I Group II
Intra operative Mean Arterial Pressure:
Time Group I Group II P value
5 min 102.34±23.38 87.84±27.40 0.005
10 min 100.08±21.18 87.72±22.15 0.005
15 min 98.6±20.40 83.7±23.11 0.0009
20 min 95.18±16.47 86.5±21.90 0.02
25 min 93.88±17.61 87.56±18.74 0.08
30 min 94.02±18.02 90.64±16.45 0.32
35 min 90.56±17.44 90.64±13.55 0.97
40 min 92.14±18.41 88.325±11.28 0.0008*
45 min 90.3±13.04 87.6±10.48 0.2
50 min 93.625±16.51 86.85±15.03 0.03
55 min 92±11.31 88.1±7.86 0.04
60 min 89.33±13.66 94.66±7.50 0.01

Intra operative MAP

120

100

80

60

40

20

0
5 min 10 min 15 min 20 min 25 min 30 min 35 min 40 min 45 min 50 min 55 min 60 min

Group I Group II
Intra operative SPO2:
Time Group I Group II P value
5 min 98.64±0.94 97.88±0.43 0.000001
10 min 98.66±0.68 98.06±0.766 0.00007
15 min 98.5±0.81 98.18±0.69 0.03
20 min 98.68±0.68 98.26±0.66 0.002
25 min 98.76±0.77 98.26±0.72 0.001
30 min 98.84±0.84 98.24±0.65 0.0001
35 min 98.94±0.54 98.16±0.69 <0.0000001
40 min 98.81±0.75 98.22±0.57 0.00002
45 min 98.83±0.69 97.93±0.7 <0.0000001
50 min 98.81±0.75 98.1±0.5 0.0000002
55 min 98.71±0.48 98.09±0.3 <0.0000001
60 min 98.66±0.51 98.33±0.577 0.003

Intra operative SPO2

99.2
99
98.8
98.6
98.4
98.2
98
97.8
97.6
97.4
97.2
5 min 10 min 15 min 20 min 25 min 30 min 35 min 40 min 45 min 50 min 55 min 60 min

Group I Group II

Intra operative ETCO2:

Time Group I Group II P value**
5 min 26.98±2.73 27.2±2.06 0.05
10 min 27.7±3.16 27.54±2.07 0.003
15 min 28.9±3.17 28.96±2.12 0.005
20 min 29.6±3.08 29.2±2.25 0.03
25 min 30.64±3.04 30.54±1.96 0.002
30 min 30.96±2.84 30.78±2.15 0.05
35 min 30.98±3.51 31.58±2.15 0.0008
40 min 30.56±3.95 31.83±2.25 0.0001
45 min 30.53±3.83 32.58±2.52 0.004
50 min 30.56±4.25 32.6±2.41 0.0001
55 min 30.85±3.33 31.2±2.82 0.24
60 min 30.66±2.06 32±0 <0.0000001
**F statistic P value
 Intra operative ETCO2
35

30

25

20

15

10

0
5 min 10 min 15 min 20 min 25 min 30 min 35 min 40 min 45 min 50 min 55 min 60 min

Group I Group II

Intra operative MAC:

Time Group I Group II P value
5 min 0.748±0.064 0.748±0.05 >0.99
10 min 0.74±0.04 0.74±0.05 >0.99
15 min 0.744±0.05 0.752±0.05 >0.99
20 min 0.744±0.05 0.748±0.05 >0.99
25 min 0.744±0.05 0.744±0.05 >0.99
30 min 0.744±0.05 0.744±0.05 >0.99
35 min 0.74±0.049 0.745±0.05 >0.99
40 min 0.73±0.05 0.747±0.05 >0.99
45 min 0.725±0.05 0.743±0.05 >0.99
50 min 0.73±0.05 0.747±0.05 >0.99
55 min 0.7±0 0.728±0 >0.99
60 min 0.7±0 0.733±0 >0.99
 Intra operative MAC
0.76
0.75
0.74
0.73
0.72
0.71
0.7
0.69
0.68
0.67
5 min 10 min 15 min 20 min 25 min 30 min 35 min 40 min 45 min 50 min 55 min 60 min

Group I Group II

Analgesic drug dose:

Time Group I Group II P value
5 min 13 8 0.23
10 min 12 8 0.33
15 min 8 4 0.04**
20 min 3 2 0.68
25 min 14 8 0.07
30 min 11 13 0.32
35 min 4 11 0.02**
40 min 5 12 0.03**
45 min 0 2 0.12
50 min 0 4 0.02**
55 min 2 0 0.12
60 min 0 0 --
 Analgesic drug dosage
16

14

12

10

0
5 min 10 min 15 min 20 min 25 min 30 min 35 min 40 min 45 min 50 min 55 min 60 min

Group I Group II

Pain:
Time Group I Group II P value
0 min 2.28±0.53 2.4±0.63 0.30
15 min 1.68±0.76 1.56±0.57 0.04**
30 min 1.22±0.46 1.02±0.14 <0.0000001**
45 min 1±0 1±0 --
60 min 1±0 1±0 --
 Pain
3

2.5

2
Group I
Group II
1.5

0.5

0
0 min 15 min 30 min 45 min 60 min

PONV:
Time Group I Group II P value
0 min 1.66 ± 0.51 1±0 <0.0000001
15 min 2±0.42 1.63±0.50 0.0001
30 min -- 1.4±0.51 --

No. of Episodes of PONV:

Time No. of episodes Group I Group II
0 min 1 1 2
2 0 4
3 0 0
15 min 1 4 1
2 7 10
3 0 1
30 min 1 0 6
2 0 4
3 0 0

No. of episodes of PONV:

PONV Group I Group II P Value
PONV at 0 minutes
Yes 1 6 0.03**
No 49 44
PONV at 15 minutes
Yes 11 12 0.4
No 39 38
PONV at 0 minutes
Yes 0 10 0.0002**
No 50 40
**Significant P value

Analgesic dosage:
Analgesic dosage Group I Group II P value
Intra OP Fentanyl 123.5±26.577 136±26.32 0.02**
Post Operative Fentanyl 32.25±11.53 33.571±14.78 0.61
**Significant P value

Analgesic dosage
160

140

120

100

80

60

40

20

0
Intra OP Fentanyl Post Operative Fentanyl

Group I Group II
 DISCUSSION

General anesthesia can be considered as a combination of hypnosis, anti-nociception,

and immobility. The monitoring of hypnosis and immobility has been established in
clinical practice, however for the evaluation of anti-nociception a valid monitoring is
missing.
To achieve the adequate analgesia (antinociception) blunting the intraoperative stress
response, most notably haemodynamic instability, it is crucial to use an ideal variable
for assessing the stress level or, perhaps more accurately, the balance of nociception-
antinociception during general Anaesthesia. An ideal (continuous, noninvasive,
accurate) variable, is still missing which may be used for guiding administration of
analgesics to attenuate the stress response. Traditionally, clinical signs, which have
been proved to be unreliable demonstrating low specificity, like somatic (movement)
or autonomic (tachycardia, hypertension, sweating, and tearing) responses are used to
evaluate whether analgesia is adequate.
Adequate hypnosis and analgesia are essential to maintaining an adequate anesthetic
depth. Several tools, including the bispectral index and spectral entropy, have been
demonstrated to reflect the depth of hypnosis well. By contrast, the administration of
analgesics still depends on conventional empirical approaches based on changes in
blood pressure and heart rate.

The newly developed surgical pleth index (SPI) monitors guides proper analgesic
administration during anesthesia using the pulse photoplethysmographic amplitude
(PPGA) and heart rate data from pulse oximetry measurements.

SPI has been demonstrated to correlate with surgical stress intensity. In the setting of
total intravenous anesthesia (TIVA) other studies had shown the beneficial effects of
SPI guided analgesia in terms of remifentanil consumption, hemodynamic stability
and incidence of unwanted events.

Therefore, we examined whether these beneficial effects of SPI guided anesthesia can
be transferred to a setting of balanced anesthesia using a volatile anesthetic isoflurane
and the opioid fentanyl.
In this prospective study, we compared the amount of intra operative fentanyl
consumption using SPI guidance with the conventional method. we conducted this
study in Yashoda superspeciality hospital, Somajiguda, Hyderabad during period of
May 2021-APRIL 2022 after approval of the research protocol by the hospital ethics
committee and written informed consent was taken from 100 patients of ASA class-I
and II, who were posted for laparoscopic surgery under general anaesthesia with
endotracheal intubation. Patients were randomized into SPI and conventional group
(50 patients in each group).

Page 88
A total of 100 patients (57 females,43 males) were included in this study. No
significant differences were noted in demographic characteristics like gender, age,
height, body weight, duration of anesthesia, duration of surgery between groups.

The SPI value was maintained within 20 to 50, consistent with previous studies. In
adults, the effectiveness of SPI for managing the nociception-antinociception balance
during general anesthesia has been demonstrated in ear-nose-throat surgery and
gynecological laparoscopic surgery.

In our study total intraoperative fentanyl consumption was lower in SPI group than in
the conventional group (123.5±26.577 µg/kg vs 136±26.32 µg/kg; p<0.02)and it was
statistically significant. SPI guided analgesia resulted in more stable hemodynamics
than in the conventional group. Postoperative pain scores were higher in conventional
group for initial 30 minutes than in SPI group (p<0.000001) then they were
comparable in both the groups and postoperative PONV scores were comparable
between these 2 groups. The postoperative fentanyl consumption in SPI group was
32.25 ± 11.53 µg/kg and in conventional group was 33.57 ± 14.78 µg/kg (p=0.61).

When we compared our study with Chen et al.in 2010 included 80 patients scheduled
for elective ear–nose–throat surgery was randomized into two groups, SSI- guided
analgesia group (SSI group) and standard practice analgesia group (control group). In
both groups, anesthesia was maintained with a propofol target-controlled infusion and
adjusted stepwise by 0.5 µg/ml to keep bispectral index values between 40 and 60. In
the SSI group, the predicted effect-site concentration of remifentanil
was adjusted stepwise by 1 ng/ml to keep SSI values between 20 and 50, whereas in
the control group, predicted effect-site concentration of remifentanil was adjusted
according to traditional inadequate analgesia criteria.
Anesthetics consumption, recovery times, and incidence of unwanted events were
recorded. Results showed that SSI guided Anaesthesia resulted in lower remifentanyl
consumption than in the control group (mean±SD,9.5±3.8µg/kg/hr.
Vs12.3±5.2µg/kg/hr.; P<0.05), The number of unwanted events was less in the SSI
group than in the control group (P<0.01). Recovery times were comparable between
groups. These results were comparable with our results. And they concluded that SSI-
guided anesthesia resulted in lower remifentanil consumption, more stable
hemodynamics, and a lower incidence of unwanted events.

Page 89
When we compared with the study conducted by Ahonen J et al. in 2007, study
included 30 women undergoing gynecological laparoscopy were assigned randomly to
receive esmolol (n=15) or remifentanil (n=15). Anaesthesia was induced with
propofol and fentanyl and maintained with desflurane and nitrous oxide 50% in
oxygen to keep SE at 50. The infusion of esmolol or remifentanil was started before
laparoscopy and adjusted to keep the systolic blood pressure at -20 to+10% from the
preoperative value.
Results shown that, during the fentanyl phase, before surgery, both groups behaved
similarly, with an increase in SSI after intubation. In the patients receiving esmolol,
the SSI reacted to the initial incision (P< 0.05), and remained high after trocar
insertion (P< 0.05). In patients receiving remifentanil, it did not react to the initial
incision, but increased after trocar insertion (P< 0.05), and it remained lower both
after incision (P< 0.05) and after trocar insertion (P< 0.05). They had shown that SSI
was higher in patients receiving esmolol and it was comparable to our study. They
concluded that the index seems to reflect the surgical stress and may help to guide the
use of opioids during general Anaesthesia.

A study by Bergmann et al.9 in 2013, a total of 170 outpatients given TIVA with
propofol and remifentanil. In this study, patients were randomized to have the
remifentanil dose either adjusted according to the SPI (SPI group) or to clinical
parameters (control group). The dosage of propofol was adjusted according to entropy
in both groups. The anesthetic drugs consumption, recovery times, and complications
were compared. The mean (SD) remifentanil and propofol infusion rates in SPI and
control groups were 0.06(0.04) vs 0.08(0.05) µg/kg/min and 6.0(2.1) vs 7.5(2.2)
mg/kg/hr. respectively (both P<0.05). Concluded that, adjusting the remifentanil
dosage according to SPI in outpatient Anaesthesia reduced the consumption of both
remifentanil and propofol and resulted in faster recovery. Results were comparable
with our study results.

Page 90
Huiku et al.in 2007, a study included 60+12 females scheduled for gynecological or
breast surgery ASA I or II under GA were included in the development and validation
data sets, respectively. All patients were premedicated with oral diazepam, were
anaesthetized with propofol and remifentanil, and muscle relaxation was achieved
with bolus doses of rocuronium or cisatracurium. Propofol and remifentanil were
administered as target control infusions (TCI). For propofol, the pharmacokinetic
model of Schnider and colleagues and for remifentanil, the pharmacokinetic model of
Minto and colleagues were used. Propofol TCI was adjusted to maintain state entropy
(SE)level between 35 and 60, the target being 50.
During general Anaesthesia, SSI correlated positively with the estimated nociceptive
stimulus (median Spearman correlation coefficient=0.56, P< 0.0001) and negatively
with the antinociceptive medication (median Spearman correlation coefficient, r = -
0.21, P< 0.0001). Median Spearman correlation with the TSS (Total Surgical Stress)
estimate was 0.48(P< 0.0001). (All Wilcoxon signed rank.)
SSI was high when noxious stimulation was high and the remifentanil concentration
was inadequate; SSI was low when the remifentanil concentration was high or the
stimulation was low. And they concluded that SSI reacts to surgical nociceptive
stimuli and analgesic drug concentration changes during Propofol – remifentanil
Anaesthesia.

A randomized double blinded control trial conducted by Park JH et al.in 2015, 45

children undergoing elective adenotonsillectomy were randomly allocated to SPI-
guided group (SPI-guided analgesia group, n = 21) or control group (conventional
analgesia group, n = 24). Anesthesia was maintained with sevoflurane 2 to 3 vol% in
50% nitrous oxide and oxygen to achieve state entropy between 40 and 60. The
primary outcome was intraoperative fentanyl requirement. Secondary outcomes
included intraoperative sevoflurane consumption, postoperative emergence agitation
and pain score, and postoperative rescue analgesic requirements.
Result shown that intraoperative fentanyl requirement was lower in SPI guided group
than in control group (0.43 ± 0.53 vs 1.73 ± 0.59 µg / kg; p < 0.001). It was
comparable to our study. Intraoperative sevoflurane consumption was similar.
Postoperative pain score and rescue fentanyl consumption were higher in SPI guided
group. In our study done on adults, intraoperative fentanyl consumption is less in SPI
group and its statistically significant(P value<\= 0.02 )where as post operative nausea
and vomiting is more or less equal in both the groups.Heamodynamic stability is more
in SPI group but its not statistically significant.

Page 91
We also found that SPI had better performance in detecting the nociception–
antinociception balance than MAP and HR. SPI guided analgesia resulted in less
analgesic consumption intraoperatively and more stable hemodynamics.
Possible limitations of this study include,

• Investigator bias in the conventional analgesia group.

• MAP was measured intermittently in our study; extremely transient episodes

of hypertension or hypotension might not have been detected.
• SPI values are not recorded in conventional group.

Page 92
 CONCLUSION

On the basis of the findings of the present study, SPI guided analgesia resulted in
lower intraoperative fentanyl consumption and more stable hemodynamics.
Postoperative pain score and rescue fentanyl administration and PONV scores were
comparable in both the groups with no statistical significance.

FUTURE SCOPE

More studies are warranted to further investigate the utility of SPI in daily clinical
practice.
• Both inadequate and excessive analgesia due to inappropriate analgesic drug
delivery during general Anaesthesia may compromise patient’s outcome.
• Hence, individualizing Anaesthesia to minimize both over- and underdosage
of anesthetic drugs during general Anaesthesia is a pursuit of modern
anesthesiologists.

Page 93
 SUMMARY

This study entitled,’’ COMPARISION OF SURGICAL PLETH INDEX –

GUIDED ANALGESIA WITH CONVENTIONAL ANALGESIA WITH
DESFLURANE ANAESTHESIA IN LAPAROSCOPIC SURGERIES-A
RANDOMISED DOUBLE BLINDED CONTROLLED TRIAL”, was undertaken
in Yashoda hospitals, Somajiguda, Hyderabad during period from MAY 2021-
APRIL2022.The study was conducted after obtaining institutional ethical clearance
and written informed consent from all the patients.
100 Patients aged between 20-65 yrs with ASA class I-II posted for laparoscopic
surgeries under GA were randomly allocated to the SPI & conventional analgesia
group using computer generated randomization table (each group 50 patients)

In SPI group, SPI value >50; In conventional group, rise in HR, BP >20% above
baseline were the criteria for fentanyl administration. Fentanyl 0.5 µg/kg was
administered in each group for an event persisted for 5 min and intraoperatively
hemodynamic stability like hypertension, hypotension, tachycardia and bradycardia
were noted. Postoperatively in the recovery room, pain and PONV scores were noted
for 1 hr. Appropriate statistical tests were applied.

It was noted that baseline patient characteristics were comparable in both the groups.
Intraoperative fentanyl consumption was higher in conventional group than in SPI
guided analgesia group. More stable hemodynamics noted in the SPI group. In the
recovery postoperative pain score, PONV score and rescue fentanyl consumption
were comparable between both the groups.
And we concluded from this study that SPI guided analgesia resulted in less fentanyl
consumption and more stable hemodynamics.

Page 94
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 Department of

RESEARCH INFORMED CONSENT FORM

Study Title:
Principal investigator / PG Guide’s Name: Dr. / Dr.
Name of the subject:
Age:
Sex:

1. I have been informed that this study requires determination of and will
not cause any harm to me.
2. I understand that my participation in the study may not have a direct benefit to me.

3. I understand that medical information produced by this study will become part of
institutional record & will be kept confidential by the said institute.
4. I understand that my participation is voluntary & I may refuse to participate or may
withdraw my consent & discontinue participation at any time without prejudice to my
present or future care at this institution.
5. I agree not to restrict the use of any data or results that arise from this study provided
such a use is only for scientific purpose (s)

I confirm that (Chief researcher/ Name of the PG guide) has

explained to me the purpose of research & the study procedure that I will undergo and the
possible risks & discomforts as well as benefits that I may experience, in my own language.
Therefore, I agree to give consent to participate as a subject in this research project.

Participant’s signature Date:

I have explained to (Subject) the purpose of the
research, the possible risks and benefits to the best of my ability.

Investigator/ P.G (Guide) signature Date:

Page 106
 INFOMRED CONSENT FORM

Participant’s name:

Address:

Phone No.

TITLE OF STUDY: “COMPARISON OF SURGICAL PLETH INDEX –GUIDED

ANALGESIA WITH CONVENTIONAL ANALGESIA WITH DESFLURANE
ANESTHESIA IN LAPAROSCOPIC SURGERIES-A RANDOMISED DOUBLE
BLINDED CONTROLLED TRIAL ”

The details of the study have been provided to me in writing and explained to me in my own
language. I confirm that I have understood the above study and had the opportunity to ask
questions. I understand that my participation in the study is voluntary and that I am free to
withdraw at any time, without giving any reason, without the medical care that will normally
be provided by the hospital being affected. I agree not to restrict the use of any data or results
that arise from this study provided. Such a use is only for scientific purpose(s). I have been
given an information sheet giving details of the study. I fully consent to participate in the
above study.

Signature of the Participant: Date:

Signature of the Witness: Date:

Page 107
Page 108
 PROFORMA

NAME: IP NO:

PROPOSED LAP SURGERY:

AGE(yrs):

GENDER: INDUCTION DRUGS:

WT(kgs): iv inj glyco

HT(metres): iv inj midaz

BMI (kg/m2): iv inj fentanyl

ASA I/II: iv inj profolol

DURATION OF SURGERY (min): iv atrac

DURATION OF ANAESTHESIA (min):

INTRA OP:

TIME HR SBP DBP MAP SPO2 ETCO2 SPI SE MAC ANALGESIC

(min) DRUG
0

10

15

20

25

30

35

40

45

50

Page
108
55

60

Page
108
65

70

75

80

85

90

95

100

105

POST OP:

TIME (min) PAIN PONV

0
15
30
45
60

Total intraoperative Fentanyl consumption: Total

postoperative Fentanyl consumption:

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Page
112