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ORIGINAL ARTICLE

The Comparative Study of Ondansetron and Metoclopramide Effects in


Reducing Nausea and Vomiting After Laparoscopic Cholecystectomy
Khatereh Isazadehfar1, Masoud Entezariasl2, Bita Shahbazzadegan3,4, Zahra Nourani5, and Yousef Shafaee6
1
Department of Community and Preventive Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
2
Department of Anesthesiology, Ardabil University of Medical Sciences, Ardabil, Iran
3
Department of Nursing, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
4
Department of Public Health, School of Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran
5
General Practitioner, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
6
Department of Surgery, School of Medicine, Iran University of Medical Sciences, Tehran, Iran

Received: 10 Aug. 2016; Accepted: 02 Jan. 2017

Abstract- Postoperative nausea and vomiting (PONV) are one of the most common complications of
anesthesia and without prophylactic intervention occurs by about one-third of patients under general
anesthesia. The aim of this study was to compare the efficacy of ondansetron and metoclopramide in reducing
PONV after laparoscopic cholecystectomy. In this study, 60 patients undergoing laparoscopic
cholecystectomy were randomly allocated into two equal groups (n=30), and in the first group 10 mg
metoclopramide and in the second group 4 mg ondansetron preoperatively were injected. Nausea and
vomiting and the need for rescue antiemetic treatment in recovery and 6 hr. and 6-24 hrs. After surgery were
evaluated. Data were analyzed by SPSS software with chi-square test and analysis of variance (ANOVA).
The incidence of nausea in metoclopramide was 43.3 % and in ondansetron was 33.3 %. The difference
between two groups was not significant (P=0.6). The incidence of vomiting in metoclopramide was 20% and
in ondansetron was 26.7%, and there was not any significant difference between intervention groups
(P=0.12). For prevention of PONV after laparoscopic cholecystectomy, both metoclopramide and
ondansetron are effective, and in preventing of nausea, ondansetron is more effective than metoclopramide,
whereas there was not any significant difference between two drugs in preventing of vomiting.
© 2017 Tehran University of Medical Sciences. All rights reserved.
Acta Med Iran 2017;55(4):254-258.

Keywords: Ondansetron; Metoclopramide; Laparoscopic cholecystectomy; PONV

Introduction for preventive intervention could significantly improve


the quality of patient care and satisfaction after surgery.
Postoperative nausea and vomiting (PONV) is a In various studies, various factors such as female
common complication of general anesthesia. PONV is gender, history of motion sickness, previous history of
still a clinical problem after anesthesia and surgery that PONV, nonsmoking and use of postoperative opioids
will cause a delay in discharge from hospital (1). have been reported as risk factors for PONV (1).
Without preventive interventions, PONV occurs in about Preventive interventions to reduce PONV include
one-third of patients (10-60%) under general anesthesia, modification of anesthesia techniques and
and its complication includes wound dehiscence, pharmacological intervention. Although preventive
bleeding, increased the risk of gastric contents interventions to prevent PONV are significantly more
aspiration, patients' delayed discharge, rehospitalisation, effective than treatment, some patients need to be treated
and decreased patient satisfaction. The most patients after surgery even after adequate preventive
believe that PONV can be even more disturbing than interventions. Both the drug categories and
postoperative pain (2). Several factors are involved in administration time are important factors to choose the
the etiology of PONV, so its extensive prevention is not appropriate drug for the prevention of this complication.
cost effective. The ability to identify high-risk patients In several studies, the effects of traditional medications

Corresponding Author: Y. Shafaee


Department of Surgery, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
Tel: + 98 21 86701, Fax: + 21 88602217, E-mail address: dr.yousefshafaei@gmail.com
Kh. Isazadehfar, et al.

(metoclopramide, perphenazine, prochlorperazine, The drugs were prepared in the same 2 cc syringes,
droperidol, and cyclizine) and 5-hydroxy tryptamine and the injection was immediately before anesthesia
receptor antagonists (ondansetron, dolasetron, induction performed by an anesthesiologist who was
granisetron, and tropisetron) have been compared in unaware of the drug kind. All patients received 1 mg of
terms of preventing PONV, and the results have been intravenous midazolam as premedication; the anesthetic
different and in some cases contradictory (3). From induction was similarly conducted on each two groups
among these medications, metoclopramide by inhibiting by 2 μg/kg of fentanyl, 2 mg/kg of propofol and 0.5
dopamine receptors at the center of medulla oblongata mg/kg of atracurium. After tracheal intubation, the
chemoreceptor trigger zone (CTZ) reduces or inhibits maintenance of anesthesia was established by propofol
nausea and vomiting. Ondansetron reduces the activity infusion 100 μg/kg/min. Muscle relaxation maintained
of the vagus nerve, which deactivates the vomiting with injection atracurium 0.25 mg/kg with intermittent
center in the medulla oblongata, and also blocks positive pressure ventilation to maintain ETCO2
serotonin receptors in the chemoreceptor trigger zone between 4.6-5.2 Kpa. At the cessation of the surgical
(4). Ondansetron is an effective drug in the prevention procedure, 0.02 mg/kg atropine and 0.04 mg/kg
and treatment of PONV by having low side effects (5). neostigmine were administered by IV to reverse muscle
Due to the minimally invasive nature and fewer relaxation, and the trachea was extubated when the
complications, comparing with open surgery, patient was awake, and respiration was adequate and
laparoscopic surgery is preferable in many patients. regular. The patients in the recovery room were
Because of its less complication, laparoscopic evaluated in terms of the incidence rate of nausea and
cholecystectomy has been selected for treating acute vomiting, a number of vomiting, the need for rescue
cholecystitis. However, it has some complications such antiemetic treatment, opioid pain therapy, and shivering
as PONV, and this leads us to identify a good way to incidence rate by anesthesiology assistant who was
control them (6). In addition, since the aim of unaware of the type of medication prescription. In
laparoscopy is a reduction of hospitalization time, if we addition, the patients were evaluated during 6 and 6-24
are able to control the PONV after laparoscopic hours after surgery, in terms of the incidence of nausea,
cholecystectomy, we will be better able to achieve our vomiting, and the need for rescue antiemetic treatment.
purpose. The aim of this study was to compare the For each case of vomiting, or nausea for more than 5
effects of metoclopramide and ondansetron in minutes, metoclopramide 10 mg was intravenously
preventing PONV after laparoscopic cholecystectomy. injected.
Considering 40% reduction in the incidence of
Materials and Methods nausea and vomiting (from 70% to 30%) in previous
studies, and the rate of α=0.05 and β=20%, the sample
In this double-blind clinical trial study (registered at size was calculated as the number of 30 patients per
Iranian Registry of Clinical Trials; registration code: group.
IRCT201111094093N3), after approval of the university The collected data in previously prepared checklists
ethical committee, written, informed consent to was entered into statistical software SPSS version 18,
participate in the study was obtained from 60 patients analysis of variance (ANOVA) was used for comparison
who were aged 15-80 years, classified as ASA physical of all continuous variables between the groups. Chi-
status I or II, and scheduled for elective laparoscopic square test was used for analysis of categorical
cholecystectomy surgery. The exclusion criteria demographic data. Differences were considered
included gastroesophageal reflux, severe obesity, significant when P<0.05.
difficult airway management, pregnancy, breastfeeding,
liver or kidney disease, history of opioid addiction and Results
alcoholism, Body Mass Index (BMI)>30, neuromuscular
diseases, mental diseases, diabetes, and gastrointestinal The main demographic and clinical characteristics of
obstruction. Using double-blind randomization the patients under investigation were not significantly
technique these patients were given either group M different between the two groups (Table 1).
(metoclopramide 10 mg) or group O (ondansetron 4
mg).

Acta Medica Iranica, Vol. 55, No. 4 (2017) 255


Ondansetron and metoclopramide in laparoscopic cholecystectomy

Table 1. Demographic and clinical characteristics of patients


Ondansetron Metoclopramide
Variables P
(n=30) (n=30)
Male 7(23.3) 4(13.3)
Gender 0.5
Female 23(76.7) 26(86.7)
Age (yr) 45.97±13.07 46.27±15.19 0.93
Weight (kg) 72.47±7.91 69.97±8.82 0.25
Urban 16(53.3) 23(76.7)
Residency 0.103
Rural 14(46.7) 7(23.3)
Smokers 5(16.6) 3(10) 0.71
Duration of operation (min) 84.67±16.01 79.23±13.42 0.16
Systolic Blood Pressure(mmHg) 128.5±10.14 132.47±11.45 0.16
Diastolic Blood Pressure(mmHg) 77.10±7.21 81.43±9.67 0.06
Heart Rate(beat/min) 81.33±12.82 82.20±13.17 0.8
Data presented as mean±SD or number (%)

The incidence of PONV and need for rescue first 6 hrs, and during 6-24 hrs after surgery is
antiemetic medication in the recovery room, during the summarized in Table 2.

Table 2. Incidence (%) of PONV and proportion (%) of patients requiring the
antiemetic medication
Ondansetron Metoclopramide
Outcome P
(n=30) (n=30)
Nausea 1(3.3) 9(30) 0.012
In recovery Vomiting 0(0) 1(3.3) 1
Antiemetic medication 0(0) 6(20) 0.024
Nausea 7(23.3) 13(43.3) 0. 17
During 6 hrs Vomiting 6(20) 5(16.7) 1
Antiemetic medication 7(23.3) 8(26.8) 1
Nausea 3(10) 0(0) 0.24
During 6-24
Vomiting 2(6.7) 0(0) 0.5
hrs
Antiemetic medication 3(10) 0(0) 0.23
Nausea 10(33.3) 13(43.3) 0.6
Entire 24hrs Vomiting 8(26.7) 6(20) 0.7
Antiemetic medication 10(33) 11(36) 1

In terms of the incidence rate of nausea in the metoclopramide groups (P=0.024). However, we
recovery room, we found the significant statistical couldn’t see a statistical difference during the first 6
difference between ondansetron and metoclopramide (P=1) and during 6-24 hrs after surgery between two
groups (P=0.012). The incidence of nausea during the groups (P=0.23).
first 6 hrs (P=0.17) and during 6-24 hours after surgery Among the patients, 5 patients (16.7%) from
was not statistically significant between two groups ondansetron group, 3 patients (10%) from
(P=0.24). In terms of the entire 24 hrs period incidence metoclopramide group had more than once vomiting
of nausea, we don't saw the statistically significant during the first 6 hours after surgery, and the difference
difference between ondansetron and metoclopramide between the mentioned groups was not statistically
groups (P=0.6). significant (P=0.06). This rate in two groups during 6-24
The incidence rate of vomiting during recovery hrs after surgery was reduced to the first 6 hrs, and the
room (P=1), the first 6 (P=1), 6-24 hrs after surgery number of vomiting between groups was not statistically
(P=0.5) and the entire 24 hrs period was not a significant different (P=0.66).
difference among the two groups (P=0.7). The incidence rate of postoperative shivering was
In terms of the need for rescue antiemetic medication not a significant difference among the groups (P=0.7).
during recovery room, there was a statistically In terms of the different factors' effect on PONV,
significant difference between ondansetron and smoking (P=0.03) and surgery duration greater than 90

256 Acta Medica Iranica, Vol. 55, No. 4 (2017)


Kh. Isazadehfar, et al.

minutes (P=0.01) significantly reduced the incidence of incidence of PONV, this difference was not statistically
this complication in the two groups. However, there was significant. Other studies also confirm high incidence of
no statistically significant difference between the PONV in young people (1).
incidence of this complication and gender and age of Like most of the studies, this study had also some
patients in different groups (P>0.05). limitations including the duration of the patients’ follow-
up. If the duration of follow-up were longer, results that
Discussion are more accurate would be obtained.
This study shows that both ondansetron and
PONV is amongst the most common complications metoclopramide are effective in reducing PONV after
following anesthesia and surgery with a selectively high laparoscopic cholecystectomy. Effectiveness rate of
incidence after laparoscopic cholecystectomy. The cause ondansetron in reducing nausea is more than
of PONV after laparoscopic cholecystectomy is complex metoclopramide, but in terms of reducing postoperative
and multifactorial and depends on various factors such vomiting, there was no significant difference between
as patients' demographic characteristics, type of two drugs.
anesthetic drugs and techniques, and postoperative cares
(7,8). Acknowledgment
In this clinical trial, patients were similar in terms of
demographic variables, duration of surgery and basic The study was supported by Ardabil University of
vital signs. In the study of entire 24 hrs period incidence medical sciences. We acknowledge the enthusiastic
of PONV among the two groups, it was observed that cooperation of our operating and recovery room staff.
nausea incidence rate and the incidence rate of vomiting
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