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179]

166 Original article

A comparative study of prophylactic intravenous granisetron,

ondansetron, and ephedrine in attenuating hypotension and its
effect on motor and sensory block in elective cesarean section
under spinal anesthesia
Omyma Sh. M. Khalifa

Department of Anesthesia, Faculty of Medicine, Context

El-Minia University, Minia, Egypt
Correspondence to Omyma Sh. M. Khalifa, MD,
Department of Anesthesia, Faculty of Medicine,
Minia University Hospital, El-Minia University,
190 El- Horria Street, Minia City 61511, Egypt
Tel: +20 106 176 2894; fax: 0862342813;
e-mail: omyma.shehata38@gmail.com
Received 15 November 2014
Accepted 25 November 2014
Ain-Shams Journal of Anesthesiology
2015, 08:166–172
Although spinal anesthesia avoids the risks involved in managing the airway of the parturient,
an undesired side effect often seen is hypotension. Prophylactic intravenous (i.v.) administration
of vasopressors such as ephedrine or of serotonin receptor antagonists such as granisetron
and ondansetron has been used to overcome this problem.
Aims
The aim of the study was to compare granisetron and ondansetron with the traditionally used
vasopressor ‘ephedrine’ in reducing hypotension following spinal anesthesia and their effect
on sensory and motor blockade in parturients undergoing cesarean section.
Settings and design
This study was designed as a randomized, prospective, double-blind, placebo-controlled
trial.
Materials and methods
Eighty parturients of ASA I or II grade, aged 2040 years, scheduled for elective cesarean
section were randomly allocated into four equal groups (G, O, E, and C). ‘Group G’ received
1 mg i.v. granisetron, ‘group O’ received 4 mg i.v. ondansetron, ‘group E’ received 10 mg i.v.
ephedrine, and ‘group C’ received 10 ml normal saline. All of the studied drugs were diluted
in 10 ml normal saline and administered over a period of 1–5 min before induction of spinal
anesthesia. Mean arterial blood pressure, heart rate, sensory and motor blockade, nausea,
shivering, bradycardia and vasopressor need were assessed.
Results
The reduction in mean arterial pressure was significantly lower in the therapeutic groups, with
the best results recorded in the O group and nearly comparable results in G and E groups.
Heart rate was statistically different only at 10 and 15 min. No significant difference was seen
in motor block or in the incidence of bradycardia. Significantly faster recovery of sensation
was detected in the G group. Groups G, O, and E had significantly less vasopressor need
and lower incidence of nausea.
Conclusion
In the cesarean section, prophylactic use of i.v. granisetron, ondansetron, or ephedrine reduced
the severity of spinal-induced hypotension, nausea, and vasopressor need, but faster recovery
of sensory block was noticed with granisetron.

Keywords:
cesarean section, ephedrine, granisetron, 5-HT, ondansetron, spinal anesthesia

Ain-Shams J Anesthesiol 08:166–172

© 2015 Department of Anesthesiology, Intensive Care and Pain Managment,
Faculty of Medicine, Ain-Shams University, Cairo, Egypt
1687-7934

Hypotension results primarily from decreased vascular

Introduction
Spinal anesthesia is a popular technique for cesarean
delivery as it is easy to perform and provides a
rapid-onset, dense surgical block. It is not associated
with maternal or fetal risk for toxicity to local
anesthetics [1], but it is associated with hypotension
and bradycardia, which may be deleterious to both
parturient and baby  [2]. Various preventive methods
are currently used to prevent or minimize hypotension,
including left uterine displacement, crystalloids or
colloid preloading, and utilizing compression stocking
onto the lower extremities [3].
1687-7934 © 2015 Department of Anesthesiology, Intensive Care and Pain Management,
Faculty of Medicine, Ain-Shams University, Cairo, Egypt
resistance, whereas bradycardia is secondary to a relative
parasympathetic dominance, increased baroreceptor
activity, or induction of the Bezold–Jarisch reflex
(BJR)  [4]. This reflex is elicited by stimulation of
peripheral serotonin receptors 5-hydroxytryptamine
(5-HT3 type). Current studies indicate that 5-HT3
antagonism may abolish the BJR response to spinal
anesthesia  [5]. Ondansetron and granisetron are
selective 5-hydroxytryptamine 3 (5-HT3) receptor
antagonists, and thus may be beneficial for preventing
bradycardia and hypotension [6]. Ephedrine, an
indirectly acting sympathomimetic amine, is probably
DOI: 10.4103/1687-7934.156667
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Granisetron, ondansetron, or ephedrine in spinal induced hypotension in C.S Khalifa
the vasopressor of choice in obstetric anesthesia.
Although ephedrine has mixed a-adrenoreceptor
and b-adrenoreceptor activity, it maintains arterial
pressure mainly by increases in cardiac output and
heart rate as a result of its predominant activity on
β1-adrenoreceptors [7].
This study aimed to compare a traditional vasopressor
‘ephedrine’ with 5-HT3 receptor antagonists
‘granisetron’ and ‘ondansetron’ in preventing
hypotension of spinal anesthesia during cesarean
section.
Materials and methods
After obtaining approval from the medical ethics
committee and informed consent from all parturients,
this comparative study was conducted in El-Minia
University Hospital during the period from June 2013
to February 2014.
Eighty parturients who were of ASA physical status I
or II, aged 20–40 years, and undergoing an elective,
cesarean section were included. Parturients with
contraindications to subarachnoid block, who refused
to participate, who had a history of hypersensitivity
to the studied drugs, who had hypertensive disorders
of pregnancy, and those receiving selective serotonin
reuptake inhibitors or migraine medications were
excluded.
Parturients were randomly allocated into four equal
groups of 20 patients each using a computer-generated
randomization chart. The study was prospectively
assigned in a double-blinded manner (neither the
anesthetist who injected the drugs and recorded the
parameters nor the patient knew the nature of the
drugs given). Patients received intravenous (i.v.) 1 mg
granisetron (G group), i.v. 4 mg ondansetron (O group),
i.v. 10 mg ephedrine (E group), or 10 ml normal saline
(C group).
All the studied drugs were diluted to a total volume of
10 ml with normal saline by the author and supplied in
similar syringes to the attendant anesthetist who was
blinded to the studied medications to inject them 5
min before starting the subarachnoid block. The same
anesthetist recorded the studied parameters.
Parturients were evaluated before surgery and
premedicated with i.v. ranitidine (1 mg/kg). In the
operating room, baseline values of noninvasive blood
pressure, ECG, and pulse oximetry (SpO2) were
recorded. A peripheral 18-G i.v. cannula was inserted
into the dorsum of the nondominant hand and the
167
patients were prehydrated with 5 ml/kg lactated
Ringer’s solution warmed to 37°C given over 15 min.
After sterilization of the back, spinal anesthesia was
induced at L3–L4, with the patient in the sitting
position, with 2 ml of 0.5% hyperbaric bupivacaine
(Marcaine; AstraZeneca, Sodertalje, Sweden) after
confirmation of free flow of cerebrospinal fluid through
a 25-G Quincke spinal needle (Typo Healthcare,
Gasport, UK). The patients were then placed in the
supine position with 15° left tilt. Intravenous fluids
were restarted, and supplemental oxygen was delivered
through a Venturi facemask at a rate of 4 l/min.
Hemodynamic data [heart rate and mean arterial
pressure (MAP)] were recorded at 5-min intervals
until the end of surgery. Rescue i.v. bolus doses of 50 μg
phenylephrine were given if the parturient became
hypotensive (hypotension was defined as a decrease in
MAP more than 20% from the baseline).
The height of sensory blockade was assessed as the
highest dermatome with loss of fine pinprick sensation
at two consecutive times. Authorization for the
surgical procedure was given only when the level of
blockade reached T5. The time to upper sensory block
(defined as the time between intrathecal injection and
achievement of the highest level of sensory blockade),
two-segment regression (defined as the time between
achievement of the highest level of sensory blockade
and its regression to a level two segments lower), and
sensory regression to T10, T12, and S1 (defined as
the time between achievement of the highest level of
sensory blockade and its regression to a level of T10,
T12, and S1, respectively) were recorded and analyzed.
The Bromage scale was used to evaluate motor block
every 2 min until complete motor block was achieved
and then every 15 min until complete recovery
(Table 1).
Any complication such as bradycardia was treated with
i.v. 0.5 mg atropine; nausea and vomiting were treated
with i.v. 10 mg metoclopramide; and shivering was
treated with i.v. 25 mg tramadol.
The above complications, in addition to the need for
vasopressor, were recorded and analyzed.
Table 1 Bromage scale [8]
Grade Criteria Degree of block (%)
I Free movement of legs and feet Nil (0)
II Just able to flex knees with free Partial (33)
movement of feet
III Unable to flex knees, but with Almost complete
free movement of feet (66)
IV Unable to move legs or feet Complete (100)
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168 Ain-Shams Journal of Anesthesiology

Statistical analysis (P = 0.001) and 15 min (P = 0.002), with a higher rate

The Statistical Program SPSS (SPSS Inc., Chicago,
Illinois, USA) for Windows, version 20, was used
for data entry and analysis. Quantitative data were
presented as mean and SD, whereas qualitative data
were presented as frequency distribution. Analysis
of variance was used to compare the means between
groups, followed by post-hoc analysis. The χ2-test
and Fisher’s exact test were used to compare between
proportions. The lowest accepted level of significance
was 0.05 or less. The sample size was calculated by
comparing the means of difference between groups by
confidence interval 95% and study power 80%.
Results
Demographic data, ASA classification, and duration of
surgery were comparable among groups (Table 2).
noticed in groups G and O, which were significantly
different from both groups E and C (Fig. 1).
The time of fixation of sensory level was insignificant
among the groups.
However, significantly faster recovery of sensation
down to the level of T12 was detected between group G
and the other groups. The same finding occurred in the
regression to S1, but did not reach statistical significance
when comparing group G with group E (Table 4).
No significant difference was present between the
groups as regards onset of complete motor block
(P = 0.624) or its regression (P = 0.591), until complete
recovery (P = 0.919).
Figure 1

There was no significant difference between the groups

as regards basal MAP, but after induction of spinal
anesthesia significant decrease in MAP was seen in
all groups compared with basal MAP, with the least
decrease occurring in the O group and the greatest in
the C group.

Those in group C had significantly lower MAP between

5 and 30 min in comparison with those in groups G,
O, and E. On comparing group O with groups G and
E, a significant difference was seen at 5, 10, and15 min
but no difference was detected between groups G and
E, except at 5 min (Table 3).

Regarding the heart rate, no significant difference Comparison of heart rate (HR) (beats/min) in the studied groups.
was detected between the groups except at 10 min AS, after spinal.

Table 2 Demographic and clinical data

Variable G group O group E group C group P-value
Age (years) 33.55 ± 17.74 31.2 ± 10.78 32.75 ± 8.53 30 ± 7.56 0.783
Weight (kg) 79.50 ± 9.47 82.80 ± 11.21 84.55 ± 13.59 81.4 ± 6.66 0.484
ASA (I/II) (n) 11/9 13/7 11/9 12/8 0.903
Operative duration (min) 49 ± 6.73 50.6 ± 4.61 48.3 ± 8.08 47 ± 5.4 0.347
Data are presented as mean ± SD and number; No significant difference between the groups (P > 0.05).

Table 3 Comparison of mean arterial blood pressure (mmHg) between and within the studied groups (mean ± SD)
MBP G group O group E group C group P-value
Basal MBP 92.8 ± 5.284 93.40 ± 4.806 93.15 ± 4.705 92.15 ± 5.779 0.883
5-min AS 80.55 ± 2.564*†‡# 90.45 ± 2.564*‡ 85.35 ± 5.797*# 75.35 ± 3.884# 0.0001
10-min AS 78.55 ± 5.326*†# 85.50 ± 5.405*‡# 78.70 ± 3.988*# 73.05 ± 6.320# 0.0001
15-min AS 76.70 ± 4.105*# 82.45 ± 3.137*‡# 77.65 ± 3.498*# 73.35 ± 6.055# 0.0001
20-min AS 79.55 ± 2.982*# 81.70 ± 3.420*# 80.05 ± 3.517*# 76.30 ± 4.889# 0.0001
25-min AS 81.25 ± 2.489*# 82.25 ± 3.127*# 81.05 ± 3.517*# 77.25 ± 4.701# 0.0001
30-min AS 83.25 ± 2.124*# 85.05 ± 3.677*# 84.35 ± 4.258*# 80.70 ± 3.570# 0.035
AS, after spinal; MBP, mean blood pressure; *Significant compared with the control group; †Significant compared with group O; ‡Significant
compared with group E; #Significant between the given time and the basal MBP in each group; P-value between the four groups (significant
P ≤ 0.05).
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Granisetron, ondansetron, or ephedrine in spinal induced hypotension in C.S Khalifa 169

On comparing the need for phenylephrine as a rescue
vasopressor, significant difference was seen among the
groups, with the greatest number of parturients who
needed vasopressor being in group C and the smallest
in group O; however, the time of first phenylephrine
requirement was not statistically different (Table 5).
Regarding the occurrence of nausea, statistical
difference was present between the study groups, and
also between each one of the therapeutic groups and
group C.
Despite the small difference in the number of cases
suffering from shivering in groups G, O, and E,
significant difference was detected between group G
and group C (Table 5).
Finally, no significant difference was present in the
incidence of bradycardia among the groups (Table 5).
Discussion
Spinal anesthesia for cesarean section may cause
hypotension, which can jeopardize the fetus and the
mother [9]. Prevention of maternal hypotension
during spinal anesthesia may result in better outcomes
compared with that following treatment after it has
occurred [10]. In the present study, a traditionally used
vasopressor in obstetric anesthesia, ‘ephedrine’, which
is a noncatecholamine sympathomimetic agent that
stimulates a- adrenergic and β-adrenergic receptors
directly and predominantly indirectly, or two 5-HT3
antagonists, ondansetron and granisetron, as they
block the BJR and may successfully treat postspinal
hypotension, were used prophylactically and given
5  min before spinal blockade with additional 50 μg
rescue boluses of phenylephrine if hypotension occurred
in an attempt to prevent spinal-induced hypotension.
To decide the doses of the studied drugs, previous
studies were revised. With regard to ephedrine,
no consensus was seen on the prophylactic i.v.
ephedrine dose that prevents spinal-induced maternal
hypotension. Loughrey et al. [11] studied 68 parturients
who received either 0.9% saline, 6 mg ephedrine, or
12 mg ephedrine. Further rescue boluses of 6 mg
ephedrine were given if hypotension was reported. They
concluded that a prophylactic bolus of i.v. ephedrine at
12 mg plus rescue boluses leads to a lower incidence of
hypotension following spinal anesthesia compared with
i.v. rescue boluses alone. Also, Vercauteren et al.  [12]
evaluated the effectiveness of a prophylactic single i.v.
dose of 5 mg ephedrine in patients prehydrated with
1000 ml of lactated Ringer’s solution and 500 ml of
6% hydroxyethyl starch who received a small-dose
spinal local anesthetic–opioid combination. Additional
ephedrine boluses (5 mg) were administered i.v. when
hypotension occurred. Their findings suggest that this
dose decreases the occurrence and limits the severity of
maternal hypotension. In previous studies, a low dose
of hyperbaric bupivacaine with intrathecal opioids and
a large volume of prehydration were used, which led to
less cardiovascular instability that could be managed
even with low doses of prophylactic i.v. ephedrine. In
the present study, a standardized dose of hyperbaric
bupivacaine, without any intrathecal opioids, was used
for spinal anesthesia to get effective block height, which
is associated with greater hemodynamic changes.
Therefore, 10 mg of ephedrine was selected and given
5 min before spinal anesthesia with 50 μg rescue boluses
of phenylephrine if hypotension occurred, as well as to

Table 4 Comparison of sensory block and recovery (min) in the studied groups (mean ± SD)
Variables G group O group E group C group P-value
Time USB (min) 10.44 ± 0.801 10.70 ± 0.865 10.75 ± 0.716 10.90 ± 0.918 0.070
Two-segment regression (min) 68.00 ± 5.231*†‡ 73.75 ± 7.759 72.75 ± 8.188 75.00 ± 5.620 0.010
Regression to T10 (min) 94.50 ± 5.596*†‡ 100.2 ± 6.129 99.7 ± 6.781 102.2 ± 6.172 0.0001
Regression to T12 (min) 114.00 ± 8.208*†‡ 129.00 ± 11.653 131.2 ± 12.863 130.0 ± 7.947 0.0001
Regression to S1 (min) 166 ± 5.151*† 170.9 ± 8.885 171.0 ± 8.046 176.0 ± 8.367 0.0001
USB, upper sensory block; *Significant compared with the control group; †Significant compared with group O; ‡Significant compared with
group E; P-value between the four groups (significant P ≤ 0.05).

Table 5 Comparison of vasopressor need and side effects

Variable G group O group E group C group P-value (%)
Rescue vasopressor 8 (40)* 6 (30)* 9 (45) 15 (75) 0.029
Time of first rescue vasopressor use (min) 7.3 ± 2.22 7.8 ± 3.52 7.4 ± 2.13 6.9 ± 2.64 0.768
Nausea 1 (5)* 0 (0)* 2 (10)* 20 (100) 0.0001
Shivering 4 (20)* 6 (30) 5 (25) 12 (60) 0.039
Bradycardia 0 (0) 0 (0) 4 (20) 4 (20) –
Data are presented as n (%) and mean ± SD; *Significant compared with the control group; P-value between the four groups (significant
P ≤ 0.05).
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170 Ain-Shams Journal of Anesthesiology
avoid the hazardous effect of high doses of ephedrine
on the fetus and prevent reactive hypertension.
The important finding in this study is that, despite
the reduction in mean blood pressure in the three
therapeutic groups, it still less than that in group C, with
significant difference recorded, with the least reduction
in mean blood pressure detected in group O and the
greatest in group C. Although significant differences
in heart rate were observed between the groups on two
occasions at 10 and 15 min, with higher rates noticed
in groups G and O, the difference was too small to
achieve statistical significance at the remaining time
points.
These findings agree with those of Tsikouris et al. [13],
who observed that infusion of granisetron diminished
heart rate fluctuations and decreased systolic blood
pressure changes during head-up tilt table tests, which
are likely related to the BJR. Further, in the study
by White et al. [14] administration of granisetron
significantly attenuated the decline of heart rate and
blood pressure in rabbits.
In line with our results, Marashi et al. [15] found that
two different doses of i.v. ondansetron, 6 and 12 mg,
significantly attenuated spinal-induced hypotension
and bradycardia compared with the control saline group.
Also, Sahoo et al. [2] concluded that i.v. ondansetron
at 4 mg given prophylactically can attenuate the
decreases in blood pressure following spinal anesthesia.
The study by Owczuk et al.[16] reported that 8 mg i.v.
ondansetron attenuates the fall of systolic and mean
blood pressure but does not have an influence on
diastolic blood pressure or heart rate.
In contrast to the present study, Mowafi et al. [17] and
Rashad and Farmawy [18] found that i.v. granisetron
administration had no effect on hemodynamic
variables. In addition, the study by Ortiz-Gómez
et al.  [19] showed that prophylactic ondansetron at
2, 4, or 8 mg i.v. had little effect on the incidence of
hypotension in healthy parturients undergoing spinal
anesthesia with bupivacaine and fentanyl for elective
cesarean delivery.
With respect to the effect of ephedrine on
hemodynamics, this study agrees with that of
Magalhães et al. [20], as a dose of 10 mg of ephedrine
was considered to be effective in the prevention of
hypotension and, at the same time, had little side
effects. As mentioned before, no consensus was found
for the dose. Thus, Iqbal et al. [21] found that a 15 mg
bolus dose of prophylactic i.v. ephedrine can effectively
prevent spinal-induced maternal hypotension without
adverse effects like reactive hypertension. In contrast,
Adigun et al. [22] found that ephedrine at 5 mg
effectively restored both the systolic and the diastolic
blood pressure during elective cesarean section under
spinal anesthesia.
On evaluating the effect of the studied drugs on motor
and sensory blockade, the groups were not significantly
different considering the motor block or recovery.
Also, no difference were found regarding onset of
upper sensory blockade; however, faster recovery of the
sensory blockade was found in the granisetron group.
These findings agree with prior studies by Mowafi
et  al.  [17] and Rashad and Farmawy [18] as they
concluded that i.v. granisetron facilitated the recovery
of sensory block after bupivacaine subarachnoid
anesthesia. Marashi et al. [15] did not observe any
significant changes in sensory block on using two
different doses of ondansetron. Further, Samra
et al. [23] concluded that i.v. ondansetron does not affect
the intensity or duration of sensory and motor block
after spinal anesthesia with hyperbaric bupivacaine.
In contrast, Fassoulaki et al. [24] reported that
ondansetron antagonizes the sensory block, but they
used hyperbaric lidocaine in their study.
The differences between the effects of ondansetron and
granisetron on sensory blockade, although both are
from the same category and have the same mechanism
of action as explained by previous studies [17,18],
may be due to the action of ondansetron on mixed
receptors and the high selectivity of granisetron on
5-HT3 receptors with little or no affinity for other
receptors [25].
Regarding the need for rescue vasopressor and
occurrence of nausea, the present study found that
the three studied drugs reduced the phenylephrine
requirement and decreased the incidence of nausea.
As granisetron and ondansetron are used primarily
for prophylaxis or treatment of postoperative nausea
and vomiting, many studies support our results in
this aspect: Gigillo et al. [26] concluded that both
granisetron and ondansetron have similar antiemetic
efficacy for prophylaxis of chemotherapy-induced
nausea and vomiting and Gupta et al. [27] found
that both granisetron and ondansetron are superior
to metoclopramide for prophylactic therapy for
postoperative nausea and vomiting (PONV ).
Regarding ephedrine, our results agree with
those of Datta et al. [28], who compared early
administration of ephedrine at 10–30 mg as soon
as any fall in basal blood pressure was detected with
i.v. boluses of 10 mg ephedrine, which was with-
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Granisetron, ondansetron, or ephedrine in spinal induced hypotension in C.S Khalifa
held until hypotension occurred. They found that
early administration of ephedrine had less nausea
alone or with vomiting.
In contrast, Jabalameli et al. [29] concluded that the
most effective method for prevention of hypotension
was administration of crystalloid preload plus
ephedrine, but there was no significant effect on the
severity of nausea.
On evaluating the occurrence of shivering, it was
found that all of the studied drugs reduced shivering
in comparison with the placebo group; however, it was
statistically significant only in the granisetron group.
These results are supported by the findings of Iqbal
et al. [30], in which prophylactic use of granisetron
(40 μg/kg) and pethidine (25 mg) i.v. was effective in
preventing postoperative shivering. Our results were
also similar to the findings of Shakya et al. [31], who
suggested that the prophylactic administration of low-
dose ketamine (0.25 mg/kg) and ondansetron (4 mg)
produces significant antishivering effect in comparison
with placebo in patients undergoing spinal anesthesia
and that ketamine (0.25 mg/kg) is significantly more
effective than ondansetron (4 mg). El-Deeb and
Barakat [32] found that prophylactic use of low-dose
ephedrine is as effective as meperidine for shivering
prophylaxis in women undergoing cesarean section
under spinal anesthesia. Moreover, it is associated with
less hypotension, nausea, and vomiting.
Conclusion
Prophylactic i.v. use of 1 mg granisetron, 4 mg
ondansetron, and 10 mg ephedrine reduces the
severity of spinal-induced hypotension, the need
for rescue vasopressor, and incidence of nausea, but
faster recovery of sensory block was noticed with
granisetron.
One of the limitations of this study are that Apgar
scores of newborns were not recorded as ephedrine has
a dose-related propensity to depress fetal pH, but our
primary focus was the effect of these drugs on maternal
hemodynamics and sensory and motor blockade of
spinal anesthesia. Also emergency and complicated
patients were not included. Finally, postoperative
nausea and vomiting, pain, and analgesic requirement
were not studied.
Acknowledgements
Conflicts of interest
None declared.
171
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