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Expert Opinion on Drug Safety

ISSN: 1474-0338 (Print) 1744-764X (Online) Journal homepage: http://www.tandfonline.com/loi/ieds20

Safety and efficacy of propofol anesthesia for


pediatric target-controlled infusion in children
below 3 years of age: a retrospective observational
study

Pyoyoon Kang, Young-Eun Jang, Eun-Hee Kim, Ji-Hyun Lee, Jin-Tae Kim & Hee-
Soo Kim

To cite this article: Pyoyoon Kang, Young-Eun Jang, Eun-Hee Kim, Ji-Hyun Lee, Jin-Tae Kim
& Hee-Soo Kim (2018): Safety and efficacy of propofol anesthesia for pediatric target-controlled
infusion in children below 3 years of age: a retrospective observational study, Expert Opinion on
Drug Safety, DOI: 10.1080/14740338.2018.1524460

To link to this article: https://doi.org/10.1080/14740338.2018.1524460

Accepted author version posted online: 15


Sep 2018.

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http://www.tandfonline.com/action/journalInformation?journalCode=ieds20
Publisher: Taylor & Francis

Journal: Expert Opinion on Drug Safety

DOI: 10.1080/14740338.2018.1524460
Article type: original research

Safety and efficacy of propofol anesthesia for pediatric target-controlled infusion in children below
3 years of age: a retrospective observational study

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Pyoyoon Kang1, Young-Eun Jang1, Eun-Hee Kim1, Ji-Hyun Lee1, Jin-Tae Kim1,2, Hee-Soo Kim1,2

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Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
2
Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University

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Corresponding author
Hee-Soo Kim

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#101 Daehak-ro, Jongno-gu, Seoul, 110-744, Republic of Korea
E-mail: dami0605@snu.ac.kr an
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Abstract

Background: Although the requirement of propofol in children is increasing, propofol for induction
and maintenance of anesthesia below 3 years old has not been approved in Korea. This study can
provide a clinical evidence to increase the range of approval.
Research design and methods: We reviewed the medical records of patients below 3 years of age
who underwent surgery between September 2013 and December 2016. Safety was evaluated on the
basis of vital signs, and laboratory findings and efficacy were evaluated on the basis of the bispectral
index (BIS). Adverse events were examined.
Results: A total of 109 patients anesthetized with propofol (propofol group) were compared with 109

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patients with volatile anesthetics (volatile group) after propensity score matching. There was a

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difference in the proportion of patients showing decreased systolic pressure (P <0.001) and heart
rate (P = 0.03), but there was no difference in diastolic pressure (P = 0.238), mean arterial pressure (P
= 0.175) during surgery. After surgery, there was no difference in all vital signs and the proportion

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patients who experienced adverse events of two groups.
Conclusions: Propofol anesthesia by target-controlled infusion was effective and didn't show serious
propofol-related perioperative adverse events.

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Keywords: pediatric anesthesia, propofol, target controlled infusion, total intravenous anesthesia
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1. Introduction
Propofol is used for induction and maintenance of general anesthesia or procedural sedation. Since
the approval of use in adults in the United States in 1989, the use of propofol has increased because
of reducing postoperative nausea and vomiting (PONV) and early recovery from anesthesia.[1] In
addition, propofol offers less reduction of electrical signals during intra-operative neurophysiological
monitoring (IONM) than volatile anesthetics.[2, 3] Propofol has been approved for induction of
anesthesia above 3 years old and for maintenance of anesthesia above 2 months old.[4] However, in
Korea, propofol for induction and maintenance of anesthesia below 3 years old has not been
approved. Therefore, in cases where the use of volatile anesthetics is limited, such as in children who
are susceptible to malignant hyperthermia or require IONM,[5] propofol is used in an “unapproved”

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manner. Although, a previous study has demonstrated that propofol is safe and efficient and exhibits

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similar hemodynamic as sevoflurane in maintenance of anesthesia below 3 years of age, [6] such
data is insufficient in the Korean.
In this study, we evaluated the safety and efficacy of propofol for maintenance of anesthesia

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using pediatric target-controlled infusion (TCI) with the model [7] that had been validated among
several types of pediatric TCI [8] in comparison with inhalational anesthesia by retrospective
evaluation of clinical data of patients below 3 years old.

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2. Patients and Methods
After obtaining approval from the institutional review board of Seoul National University Hospital for
retrospective record review and a waiver for informed consent for this study, we reviewed the
medical records of patients below 3 years of age who underwent an operation under general
anesthesia with Total intravenous anesthesia (TIVA) using TCI [propofol group] or volatile anesthetics
[volatile group] between September 2013 and December 2016. We used Kim HS model which was
already externally validated for TCI of propofol. The Kim HS model was run through a computer
installed with the Asan pump program and Pilot Anesthesia 2 was used among the syringe pumps
such as Bionet, Pilot Anesthesia 2, Graseby 3400, and Graseby 3500 which can drive the Asan pump
program. Data were excluded in cases where there was a change in the protocol for maintenance of

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anesthesia. All information for evaluating the efficacy and safety of propofol, including basic

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demographic data, was collected. In addition, the history of TCI was obtained from the computer
that was connected to the syringe pump.

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2.1. Anesthetic Managements
2.1.1. Propofol group
Without premedication, electrocardiogram, pulse oximetry, non-invasive blood pressure and

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bispectral index (BIS) were monitored and recorded throughout the operation in all patients.
According to the institutional clinical protocol, anesthesia was induced with thiopental (5 mg·kg-1)
and atropine (0.02 mg·kg-1, up to 0.5 mg) intravenously via intravenous catheter prepared one day
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before the surgery, after pre-oxygenation using a facial mask with 100% oxygen. All patients who will
undergo the surgery under general anesthesia are admitted one or two days before the surgery for
preoperative evaluation and preparing intravenous catheter in the Seoul National University
Children's Hospital. Anesthesia was maintained with propofol and opioids (sufentanil or remifentanil)
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followed with 0.6 mg·kg-1 of rocuronium. After confirming target BIS (40-60) and muscle relaxation in
all patients, appropriate size of endotracheal tube was intubated. The initial target of propofol
concentration was 3 mcg·ml-1 of effect site concentration and adjusted by patient's vital signs and BIS
value during maintenance.
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2.1.2. Volatile group


Without premedication, electrocardiogram, pulse oximetry, non-invasive blood pressure were
monitored and recorded throughout the operation in all patients. The BIS was monitored only 3
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patients in volatile group as BIS was not a routine monitor during volatile general anesthesia unlike
TIVA in our institute. According to the institutional clinical protocol, anesthesia was induced with
thiopental (5 mg·kg-1) and atropine (0.02 mg·kg-1, up to 0.5 mg) intravenously via intravenous
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catheter prepared one day before the surgery, after pre-oxygenation using a facial mask with 100%
oxygen. Anesthesia was maintained with sevoflurane or desflurane followed with 0.6 mg·kg-1 of
rocuronium. After confirming muscle relaxation, appropriate size of endotracheal tube was intubated.
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The concentration of volatile anesthetics was adjusted by patient's vital signs and if possible, also by
BIS value during maintenance.

2.2. Outcome Measures


2.2.1. Safety
Safety was evaluated on the basis of vital signs and laboratory findings. Vital signs—including heart
rate (HR), systolic (SBP)/diastolic (DBP) blood pressure, mean arterial pressure (MAP), and oxygen
saturation—were recorded in the ward, operating room, and PACU or ICU until postoperative day 1.
Significant changes in vital signs were considered in case of a reduction or increment of 20% or more,
relative to the baseline values. Baseline values were defined by the mean values of vital signs
measured at least three times in the ward.
Pre and postoperative laboratory findings—including blood gas analysis, lactate (evaluation
of lactic acidosis as an early finding of propofol infusion syndrome [PRIS]), blood urea nitrogen (BUN),
creatinine (evaluation of renal function), aspartate aminotransferase (AST), and alanine
aminotransferase (ALT) concentrations, and prothrombin time (evaluation of hepatic function)—
were compared. Blood–gas analysis was performed using the GEM Premier 3000 analyser
(Instrumentation Laboratory/Werfen Group, Barcelona, Spain). The degree of acidosis was classified
into mild (pH 7.25-7.35), moderate (pH 7.15-7.25) and severe (pH under 7.15).

2.2.2. Efficacy
For effective general anesthesia by TCI in children, depth of anesthesia was controlled on the basis of
BIS values, which were maintained between 40 and 60 during anesthesia, as validated in adults[9, 10]
and children.[11, 12] Although the attending anesthesiologist tried to maintain the BIS values

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between 40 and 60 during anesthesia, blood pressure and HR were more important guidelines[13,

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14].

2.2.3. Adverse Events

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Adverse events were classified as follows:
- Intra-operative adverse events
 Major events: cardiac arrest or death

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 Minor events: hypotension or bradycardia requiring treatment or desaturation < 95%
requiring assisted ventilation
- Postoperative adverse events
 Major events: cardiac arrest, death, apnea >30 seconds requiring mechanical
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ventilation, seizure resulting in neurologic sequelae, or unexpected hospitalization
 Minor events: desaturation < 95% requiring assisted ventilation, laryngospasm or
bronchospasm, or nausea and vomiting
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Recovery profile was evaluated using a postanesthetic scoring system[15] in PACU.

2.3. Statistical Analysis


A propensity score analysis was used to match patients with two anesthesia groups to reduce any
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potential selection bias from demographic factors and surgery-related parameters. Patients were
matched using a greedy method with 1:1 pair. The following variables were used as contributors to
the propensity score: age, sex, weight, height, ASA classification, anesthesia time, surgery time. The
caliper was defined as 0.1 standard deviations of the logit-transformed propensity score. The balance
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between the two groups was tested using standardized difference (>0.10 represents imbalance). The
clinical outcome variables were compared in the matched cohort.
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Continuous data are presented as mean and standard deviation, and categorical data are presented
as absolute frequency and percentage. Comparison between categorical variables were performed
using Pearson’s χ2 test. Two-sided P values ≤0.05 were considered statistically significant. All
statistical analyses were performed using the SPSS software version 22.0 (IBM Corp., Armonk, NY,
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USA). Propensity score matching was conducted by Propensity Score Matching for SPSS version 3.0.4.
3. Results
A total of 408 electronic medical records were retrieved within the study period, of which, 26 were
excluded because of loss of data and 34 were excluded because of short anesthetic duration. Then,
173 children for the propofol group and 175 children for the volatile group remained. Through the
propensity score matching, a total of 109 patients with inhalational anesthesia were matched with
109 patients with total intravenous anesthesia using the nearest neighbor matching, thus the
propensity score-matched group set comprised of 218 patients in total. The balance of both the
volatile and the propofol groups was good for the parameters used for contributors to the propensity
score (overall balance test: χ2=4.05, P=0.853) The histogram and covariate balance plot of
distribution of standardized differences in the propensity scores between the groups are shown in

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Figure 1. The demographic data of both groups, before and after propensity score matching, are

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shown in Table 1.
In the propofol group, most of the children (n=102, 93.6%) were anesthetized with propofol

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for IONM, and 7 (6.4%) were susceptible or suspected of being susceptible to malignant
hyperthermia. While most of the children (n=102; 93.6%) were scheduled to undergo neurosurgery,
the rest were scheduled to undergo orthopedic, otorhinolaryngologic or pediatric surgery. The

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average total amount of administered propofol was 369.8 (± 276) mg, and the average infusion rate
was 10.7 (± 2.77) mg·kg-1·h-1.
After surgery, 53 children in volatile the group and 74 children in the propofol group were
transferred to the PACU, while 56 and 35 children in the volatile and the propofol group respectively
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were moved to the ICU. This was decided depending on the postoperative care plan, not on
children's condition.

3.1. Intra-operative Safety and Adverse Events (Table 2)


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As shown in table 2, 12.8% of children in the propofol group and 33% of children in the volatile group
showed significant decrease in SBP (P <0.001) during anesthetic maintenance. However, DBP showed
a significant decrease in 11.0% and 16.5% of patients in the propofol and the volatile group (P=0.238),
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and MAP showed a significant decrease in 6.4% and 13.8% of patients in each group (P=0.175). There
was no statistically significant difference between two groups. Heart rate during anesthesia was
significantly decreased in 8.3% of patients in the propofol group and 1.8% of patients in volatile
group (P=0.030). In the propofol group, 10.1% of children needed a dopamine agonist for
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maintaining blood pressure and HR during anesthesia, whereas, 34.0% of children needed a
dopamine agonist in the volatile group (P <0.001).
Only one child in the volatile group was required cardiopulmonary resuscitation (CPR). The
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return of spontaneous circulation was achieved after one cycle of cardiac massage and rapid infusion
of blood products according to the record. The point of care test result at the point of cardiac arrest
showed abrupt decline of hemoglobin level and massive bleeding was recorded. Therefore, the
cardiac arrest seems to be caused by bleeding rather than by anesthesia itself.
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Intra-operative desaturation events (<95%) occurred in 6 children in the propofol group, but
they all recovered with lung recruitment maneuvers. There were no instances of laryngospasm or
bronchospasm during anesthesia. In the volatile group, desaturation events occurred in 8 patients:
while 1 underwent CPR during the surgery, 7 recovered with lung recruitment maneuvers or
endotracheal suction.
Of the 22 patients who exhibited acidosis in the propofol group, 10 had acidosis before
surgery as well, while 12 exhibited a decrease in pH during surgery. All of 22 patients exhibited mild
acidosis and did not receive any treatment for correction of mild acidosis; acidosis was not severe
enough in any of these cases to warrant correction. There was no patient who exhibited moderate or
severe acidosis in the propofol group. Of the 32 patients who exhibited acidosis in the volatile group,
6 had acidosis before surgery as well. Of remained 26 patients, 2 patients showed moderate acidosis,
one of them was patient who underwent CPR during surgery and treated with sodium bicarbonate.
The other 31 patients didn’t receive any treatment for correction of acidosis. Since there were no
additional test results after anesthesia, it is not known whether these instances of mild acidosis
recovered after surgery.

3.2. Postoperative Safety and Adverse Events


Postoperative desaturation events occurred in 22 patients in the propofol group and 23 patients in
the volatile group respectively. Two patients in the propofol group and 3 in the volatile group had
major desaturation events requiring mechanical ventilation, but the remaining patients recovered
spontaneously or with brief oxygen supply.
Of 14 patients who experienced PONV in the propofol group, 13 had undergone

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neurosurgery, while 1 had undergone pediatric surgery. All of 13 patients who experienced PONV in

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the volatile group had undergone neurosurgery.
Of 5 patients who experienced postoperative seizures in the propofol group, 2 had been
treated for underlying epilepsy, while the remaining had undergone surgery for brain tumors. All of 2

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patients who experienced postoperative seizures in the volatile group had been treated for
underlying epilepsy. None of these 7 patients exhibited new neurologic abnormalities after surgery.
There were no instances of laryngospasm or bronchospasm, cardiac arrest, or death during

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the observation period after surgery.
Table 3 presents the results of pre and postoperative laboratory tests performed for
evaluation of renal and hepatic function. While there was no increase in BUN levels after surgery in
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any of the patients of both groups, 11 patients in the propofol group and 4 patients in the volatile
group exhibited increased creatinine levels postoperatively. Seven Of the 11 patients in the propofol
group and all 4 patients in the volatile group had elevated creatinine levels pre-operatively as well. In
the propofol group, 5 patients showed elevated liver enzyme levels and 4 in the volatile group after
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surgery. All of 5 patients in the propofol group and 3 patients in the volatile group showed elevated
liver enzyme levels before surgery as well. Abnormalities were resolved spontaneously, and none of
the patients received treatment for correction of abnormal biochemical parameters.
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3.3. Intra-operative Efficacy


All patients received anesthesia with propofol in the TCI mode, with the target BIS being maintained
between 40 and 60 during anesthesia. Therefore, the efficacy of propofol anesthesia was evaluated
on the basis of BIS values. The mean BIS during anesthesia was 54.2, which indicated the efficacy of
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TCI for anesthesia in children below 3 years of age. In the propofol group, the mean BIS during
anesthesia was 48.8.
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4. Discussion
In this study, we demonstrated the safety and efficacy of TCI of propofol as a main
anesthetic agent for children below 3 years of age. Despite the convenience of volatile anesthetics,
requests for TIVA have increased because of reduced emergence agitation in children[16] and for
IONM, an important aspect of surgery as mentioned above. Recently, IONM techniques have been
applied to children,[17] especially in younger children, whose motor system is still under
development, which renders IONM more challenging.[18] Although, a previous study demonstrated
that a volatile agent-based anesthetic regimen is feasible even during neurophysiologic monitoring in
adolescents,[19] halogenated anesthetics should not be used in younger children, because they
elevate muscle motor evoked potential (MEP) stimulus thresholds and block muscle MEPs.[20] In

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addition, attenuation of atmospheric pollution from venting of greenhouse gases is also another

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reason of increased demand of TIVA.[21, 22]
With this increased demand for TIVA, there is a need for evaluation of its safety and efficacy
and so far, many studies have been conducted. A systemic review that compares propofol and

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volatile agents for maintenance of anesthesia during elective craniotomy concluded that propofol
was associated with fewer intra-operative hypotension than the volatile agents and there was no
significant difference in the incidence of intra-operative hypertension, bradycardia, or

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tachycardia.[23]
In the present study, 12.8% of patients experienced hypotension during anesthesia; this
percentage is lower than those reported in previous studies[24, 25, 26]. However, this discrepancy
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might be attributable to differences in the definition of hypotension between the studies. Heart rate
is an important factor in maintenance of cardiac output, particularly in children. In the present study,
HR was more consistently maintained during propofol anesthesia than BP — this is an encouraging
finding, despite the expected bradycardia. This finding indicates that TCI of propofol as a main
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anesthetic agent elicits safe hemodynamic responses in children below 3 years of age.
In the pediatric populations, concerns regarding propofol over dosage arise from the PRIS
that is characterized by bradycardia, metabolic acidosis, rhabdomyolysis, and heart and kidney failure.
The PRIS can occur when propofol is used over prolonged periods (> 48 h) and at high dosages (> 4
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mg·kg-1·h-1) to sedate children. There have been observed several cases of presumptive PRIS —
propofol infusion-associated metabolic acidosis is an early marker of PRIS[27] — after short-term
infusion of propofol in adults[28, 29] and children[30, 31], however, when lactic acidosis was
observed, cessation of propofol infusion led to prompt recovery. A previous study has also reported
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that short-term use of propofol did not result in significant adverse effects.[32, 33] Dosages > 4
mg·kg-1·h-1 are high for sedation, but the dosages for general anesthesia may vary. A clinical
guideline[34] for the rate of propofol infusion states that propofol should be infused at a rate of 9–15
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mg·kg-1·h-1 depending on the duration of anesthesia. As the infusion duration was not a big deal in
this study when considering the risk of PRIS, we calculated the total dose of propofol administered
by the computer using TCI and divided it with the patient's body weight and the infusion duration.
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The average rate of propofol infusion during the maintenance period of anesthesia was 10.8 mg·kg-
1·h-1 in the present study, which is not greater than the rate of manually controlled infusion. None of
the patients in the present study exhibited metabolic acidosis; none of the patients experienced
impairment of cardiac or renal function, either. There was no evidence of PRIS among the present
subjects.
To evaluate kidney function, BUN and creatinine levels were compared before and after
surgery, and liver enzymes before and after surgery were compared to assess liver function. All
children with abnormal findings in the laboratory test didn't show signs of renal or hepatic
dysfunction and the laboratory results showed a tendency to improve spontaneously without
treatment. Thus, the present findings support the position that infusion of propofol in children below
3 years of age does not cause renal, or hepatic adverse effects.
The duration of stay in the PACU in the present study was approximately 50 min; this is
similar to the time reported in a previous study.[35]
The present study has several limitations. Firstly, as it is not a randomized controlled study
that is preferred in current human studies, it is difficult to control confounders and bias in both
groups. However, we have tried to reduce the bias through propensity score matching. Secondly, it is
difficult to establish cause and effect in retrospective studies; prospective studies should be
considered to address this aspect of the study. Moreover, it is difficult to distinguish between errors
of recorded values due to external stimuli and actual problems. All authors re-examine the recorded
data to reduce this problem. Also, as we mentioned above, we could get only several BIS result in the
volatile group because BIS was not a routine monitor in this group and the sensor was expensive in
our country. In the volatile group, the BIS was recorded manually by the attending anesthetist every
20-30 minutes unlikely the propofol group whose BIS was recorded continuously in the computer to

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which the syringe pump is connected, it was difficult to evaluate the relationship between the

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concentration of the volatile agent or the changes of vital signs and BIS value. Further well designed
prospective studies are needed to clarify the relationship in both groups. Lastly, because we
anesthetized patients if the benefit expected to be greater than the risk of using intravenous

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anesthesia, the interindividual variability is lack and the sample size of this study is small to detect
uncommon complications.
However, the advantage of the present study lies in the fact that the safety and efficacy of

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propofol was evaluated using over 200 medical records of young patients under the age of 3.
Moreover, conducting clinical trials in such patients poses ethical and also economic problems in
terms of market size. In these aspects, this retrospective study might serve as a cornerstone in the
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use of propofol in the target-controlled infusion mode in patients below the age of 3 years in need of
propofol anesthesia.
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5. Conclusions
In this study, we retrospectively investigated the safety and efficacy of general anesthesia
through continuous infusion of propofol by TCI in children younger than 3 years of age, whose
demand is increasing gradually. The propensity score matching method was used to reduce the
potential bias that might occur in the research method itself. The maintenance of anesthesia
through propofol TCI was not harmful compared to maintenance of anesthesia through
inhalation anesthetics, based on hemodynamic changes during surgery, changes in laboratory
tests before and after surgery, and recovery time after surgery. In addition, there was no critical
complication after surgery and the BIS values were maintained at the desired target range.
In conclusion, propofol anesthesia in the TCI mode is safe and efficient in children below 3

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years of age. There were no serious intra or postoperative adverse events related to propofol in

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this study.

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Funding
This research was supported by a grant of the Korea Health Technology R&D Project through the
Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare,
Republic of Korea (grant number: HC15C1523).

Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with
a financial interest in or financial conflict with the subject matter or materials discussed in the
manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert
testimony, grants or patents received or pending, or royalties.

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Review disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

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Author contributions
PK: This author helped to acquire and interpret the data and to write the manuscript. Y-EJ: This
author helped to acquire, analyze and interpret the data. E-HK: This author helped to design the

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study and to analyze the data. J-HL: This author helped to design the study and to analyze the data.
J-TK: This author helped to design the study, interpret the data and draft the manuscript. H-SK: This
author helped to design the study, analyze and interpret the data, draft the manuscript and approve
the final version to be published.
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Acknowledgements
The authors are sincerely grateful to Professor Won-Ho Kim for his statistical guidance in propensity
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score matching.
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Figure 1. Line ploot (left) and
d covariatee balance pllot (right) of
o distributiion of stand
dardized

differennces in the propensity


p scores
s betw
ween patients with the volatile
v grouup and the propofol
p

group. Values in the X-axiss represent the percen


nt standard
dized differrence of co
ovariates

betweenn the two grroups.

t
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cr
us
an
M
ed
pt
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Table 1. Demographic characteristics
Before propensity score matching After propensity score matching
Propofol Volatile P value Propofol Volatile P value
Gender, n (%)
Male 92 (53%) 101 (58%) .395 57 (52%) 57 (52%) 1.0
Female 81 (47%) 74 (42%) 52 (48%) 52 (48%)
Age, years
Mean (SD) 0.99 (0.67) 0.69 (0.57) <0.01 0.89 (0.61) 0.85 (0.66) .538

t
Ranges 0.01-2.9 0.01-2.7 0.01-2.3 0.01-2.7

ip
Weight, kg
Mean (SD) 8.7 (2.9) 8.4 (2.3) .399 8.7 (2.7) 8.7 (2.6) .785

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Ranges 2.2-16.2 2.32-15.4 2.4-15.7 2.3-15.4

Height, cm

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Mean (SD) 70.9 (11.7) 68.5 (10.0) .243 70.31 (10.71) 69.87 (11.82) .917
Ranges 44.0-97.0 38.3-96.9 44.0-96.2 38.3-92.3

ASA class, n (%)


an
I 61 (35%) 102 (58%) .000 47 (43%) 36 (33%) .282
II 91 (53%) 62 (36%) 51 (47%) 62 (57%)
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III 21 (12%) 11 (6%) 11 (10%) 11 (10%)
Surgical time, 235.1 (145.1) 168.5 (115.6) .000 220.4 (132.6) 204.1 (134.0) .062

min
ed

Anaesthetic time, 310.1 (153.0) 243.6 (122.0) .000 298.9 (143.3) 278.0 (141.1) .077

min
pt

ASA, American Society of Anaesthesiologists


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Table 2. Vital signs and adverse events
Propofol group Volatile group P value

Intraoperative vital signs

Systolic blood pressure

< 80% 14 (12.8%) 36 (33%) 0.001

80~120% 94 (86.2%) 73 (67%)

> 120% 1 (0.9%) 0 (0.0%)

t
ip
Diastolic blood pressure

< 80% 12 (11.0%) 18 (16.5%) 0.238

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80~120% 82 (75.2%) 82 (75.2%)

> 120% 15 (13.8%) 9 (8.3%)

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Mean arterial pressure

< 80% 7 (6.4%) 15 (13.8%) 0.175


an
80~120% 89 (81.7%) 89 (81.7%)

> 120% 13 (11.9%) 5 (4.6%)


M
Heart rate

< 80% 9 (8.3%) 2 (1.8%) 0.030


ed

80~120% 95 (87.2%) 76 (69.7%)

> 120% 5 (4.6%) 31 (28.4%)


pt

Dopamine infusion 11 (10.1%) 37 (34.0%) <0.001

Desaturation 6 (5.5%) 8 (7.3%) 0.581


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Postoperative vital signs

Systolic blood pressure


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< 80% 7 (6.4%) 5 (4.6%) 0.553

80~120% 92 (84.4%) 80 (73.4%)

> 120% 10 (9.2%) 24 (22.0%)

Diastolic blood pressure

< 80% 4 (3.7%) 5 (4.6%) 0.734

80~120% 37 (33.9%) 32 (29.4%)


> 120% 68 (62.4%) 72 (66.1%)

Mean arterial pressure

< 80% 18 (16.5%) 17 (15.6%) 0.854

80~120% 71 (65.1%) 57 (52.3%)

> 120% 20 (18.3%) 35 (32.1%)

Heart rate

t
< 80% 6 (5.5%) 7 (6.4%) 0.775

ip
80~120% 60 (55.0%) 55 (50.5%)

cr
> 120% 43 (39.4%) 47 (43.1%)

Postoperative desaturation 22 (20.2%) 23 (21.1%) 0.867

us
Major desaturation 2 (1.8%) 3 (2.8%) 0.652

Nausea/Vomiting 14 (8.1%) 13 (7.4%) 0.817

Seizure 5 (2.9%)
an 2 (1.1%) 0.246

PACU discharge, min 51.7 ± 21.1 56.9 ± 19.9 0.760


M
Total hospital stays, days 9.4 ± 11.6 8.9 ± 8.9 0.536

* Data are expressed as mean ± SD.


TIVA, total intravenous anaesthesia; IONM, intra-operative neurophysiologic monitoring; MH, malignant
ed

hyperthermia; PACU, post anaesthetic care unit; ICU, intensive care unit; BIS, bispectral index™
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Table 3. Surgical characteristics and Anesthetic Data;
Propofol Volatile P value

Intraoperative

pH

Initial 7.39 (0.06) 7.39 (0.06)

Last 7.38 (0.06) 7.37 (0.08)

Mild acidosis 22 / 81 30 / 103 0.076

t
ip
Moderate acidosis 0 / 81 2 / 103 0.207

Lactate, mg·dL-1

cr
Initial 0.72 (0.48) 0.98 (0.52)

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Last 0.79 (0.87) 1.31 (0.94)

Number / Total 3 / 77 8 / 101 0.269

Difference 0.07 (0.59)


an 0.32 (0.76) <0.001

Base Excess, mmol·L-1


M
Initial -2.21 (2.95) -2.02 (3.09)

Last -2.75 (3.30) -3.46 (3.33)


ed

Number / Total 55 / 81 69 / 103 0.896

Difference -0.51 (2.24) -1.50 (2.82) 0.022


pt

Postoperative

Blood urea nitrogen, mg·dL-1


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Initial 9.4 (3.4) 9.2 (3.9)

Last 7.0 (2.5) 7.3 (2.9)


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Number / Total 0 / 94 0 / 106 .

Difference -2.25 (2.72) -1.81 (3.48) 0.110

Creatinine, mg·dL-1
Initial 0.30 (0.20) 0.26 (0.07)

Last 0.22 (0.09) 0.20 (0.07)

Number / Total 11 / 94 4 / 106 0.061

Difference -0.08 (0.21) -0.06 (0.07) 0.963

Aspartate aminotransferase, U·L-1

Initial 42.66 (35.65) 41.13 (36.07)

t
ip
Last 33.72 (37.41) 30.19 (25.33)

Number / Total 5 / 94 4 / 106 0.734

cr
Difference -9.10 (11.16) -10.81 (15.52) 0.309

us
Alanine aminotransferase, U·L-1

Initial 26.79 (30.93) 31.02 (51.84)

Last 20.26 (32.60)


an
20.26 (27.75)

Number / Total 5 / 94 3 / 106 0.471


M
Difference -6.47 (7.97) -10.81 (20.44) 0.033

Prothrombin time, sec

Initial 11.62 (1.08) 11.29 (1.05)


ed

Last 12.86 (1.29) 13.48 (1.81)

Number / Total 5 / 89 18 / 107 0.004


pt

Difference 1.23 (1.00) 2.12 (1.73) <0.001


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* Data are expressed as mean (SD).


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