|Year : 2018 | Volume
| Issue : 1 | Page : 24-28
Comparison of ondansetron and metoclopramide for the prevention of post-operative nausea and vomiting in day-case gynaecological laparoscopic surgeries
Salahu Dalhat, Alhassan D Mohammad
Department of Anaesthesiology and Intensive Care, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria
|Date of Web Publication||23-Mar-2018|
Dr. Salahu Dalhat
Department of Anaesthesiology and Intensive Care, Bayero University Kano/Aminu Kano Teaching Hospital, Kano
Source of Support: None, Conflict of Interest: None
Background: Postoperative nausea and vomiting is a common complication following general anaesthesia for gynaecological laparoscopic procedures. Objective: This prospective study was designed to compare the efficacies of ondansetron and metoclopramide in the prevention of postoperative nausea and vomiting (PONV) after day-case gynaecological laparoscopic surgeries. Materials and Methods: Sixty-six ASA I and II consenting patients aged 18–55 years undergoing day-case gynaecological laparoscopic procedures were recruited and randomly allocated into two groups with each receiving either intravenous ondansetron 4 mg or intravenous metoclopramide 10 mg prior to the induction of anaesthesia. Nausea and vomiting were then assessed over a period of 4 hours before discharge. Results: Nausea occurred in 33.3% and 15.2% of the patients in the metoclopramide and ondansetron groups, respectively (P = 0.001). The incidence of vomiting was 9.1% and 3% (P < 0.0001) for metoclopramide and ondansetron, respectively. Conclusion: Ondansetron offered superior prophylaxis against PONV compared to metoclopramide in patients undergoing day-case gynaecological laparoscopic surgery.
Keywords: Metoclopramide, nausea, ondansetron, vomiting
|How to cite this article:|
Dalhat S, Mohammad AD. Comparison of ondansetron and metoclopramide for the prevention of post-operative nausea and vomiting in day-case gynaecological laparoscopic surgeries. Niger J Basic Clin Sci 2018;15:24-8
|How to cite this URL:|
Dalhat S, Mohammad AD. Comparison of ondansetron and metoclopramide for the prevention of post-operative nausea and vomiting in day-case gynaecological laparoscopic surgeries. Niger J Basic Clin Sci [serial online] 2018 [cited 2021 Jun 16];15:24-8. Available from: https://www.njbcs.net/text.asp?2018/15/1/24/228351
| Introduction|| |
Postoperative nausea and vomiting (PONV) is one of the most common complaints following anaesthesia. It is an unpleasant and distressing experience which can delay discharge. Along with pain, PONV is usually listed by patients as their most important perioperative concern. PONV is typically seen following laparoscopic surgeries, with incidences as high as 70%. This is due to pneumoperitoneum causing stimulation of mechanoreceptors in the gut. The consequences of PONV could be physical, metabolic and economic in nature. In severe cases, vomiting may result in bleeding at the operation site, oesophageal tear, gastric herniation, wound dehiscence, aspiration of vomitus, fluid and electrolyte imbalance. This could lead to unplanned admission and prolonged hospital stay by approximately 3 to 4 times. Factors that have been found to be contributory to PONV include age, gender, body mass index, previous history of PONV and motion sickness. Younger age group, obese and female gender are especially vulnerable. The female gender is one of the strongest predictors of PONV. Other predisposing factors include type of surgical procedure (laparoscopic, gynaecological, abdominal, middle ear surgery), use of opioids and nitrous oxide., Therefore, patients undergoing laparoscopic gynaecological surgery are particularly prone to PONV.
The use of antiemetic drugs remains the main form of prevention and treatment of PONV, and patients at risk of developing PONV have to receive prophylactic doses of antiemetic drugs. Commonly used antiemetics such as promethazine, metoclopramide and droperidol are known to cause adverse effects such as dry mouth, sedation, hypotension, tachycardia, extrapyramidal reactions, dystonic effects and restlessness. The 5HT3 receptor antagonists are devoid of these side effects. Five principal neurotransmitter receptors mediate nausea and vomiting: muscarinic M1, dopamine D2, histamine H1, serotonin 5HT3 and substanceP neurokin 1. Serotonin receptors are found in the chemoreceptor trigger zone and/or vomiting centre, thus serotonin plays an important role in PONV. Ondansetron, a 5HT3 receptor antagonist, is known to be effective in the prevention of PONV. Metoclopramide, a dopamine antagonist, acts on the chemoreceptor trigger zone (CTZ) to produce its antiemetic effect. It is much cheaper and more affordable than ondansetron but is associated with extrapyramidal effects, tardive dyskinesia and hyperprolactinaemia.,
This study seeks to compare the efficacy of ondansetron and metoclopramide in preventing PONV in a high-risk group of Nigerian patients undergoing laparoscopic gynaecological procedures.
| Materials and Methods|| |
This was a prospective double-blind, randomised controlled study conducted in a tertiary health facility in Northwest Nigeria. Following approval from the research ethics committee, patients' informed consent were sought. Sixty-six consenting American Society of Anesthesiologist risk classification status I or II patients aged between 18 and 55 years and scheduled for day-case gynaecological laparoscopic surgeries were recruited into the study. Patients who had either known sensitivities to the study drugs, received antiemetics 24 hours prior to surgery, history of motion sickness or previous PONV were excluded from the study.
The formula for determining sample size for comparative studies  was used to deduce the sample size as
n = minimum sample size for each of the compared groups
za= standard normal deviation set at 95% confidence level of 1.96
zβ= Standard normal deviation for the power of test to detect difference between ondansetron and metoclopramide set at 80% power corresponding to 0.84
II = arithmetic average of the two proportions = (p2 + p1)/2
△ = arithmetic difference between the two proportions = (p2 − p1)
To calculate the sample size for each group therefore,
P1 = proportion of patients with no nausea and vomiting after administering ondansetron 65.5% = 0.655
P2 = proportion of patient with no nausea and vomiting after administering metoclopramide 29.2% = 0.292 (based on previously published study by Naguib et al.). Therefore,
Π = (0.655 + 0.292)/2 = 0.4735
△ = 0.655 − 0.292 = 0.363
n = 2 (1.96 + 0.84) 2 × 0.4735 (1 − 0.4735)/(0.363)2
n = 2 × 7.84 × 0.4735 × 0.5265/0.131769
= 29.665 i.e., approximately 30 patients per each group.
Allowing for an estimated 10% drop-out rate increased the sample size to 33 patients in each group. The total sample size was therefore 66 patients.
Routine pre-anaesthesia evaluation was carried out in all patients on the morning of the surgery. Patients were randomly assigned into one of two groups A (ondansetron) or B (metoclopramide) using sealed envelope technique. They were asked to pick from a bag containing sealed envelopes and hand over the same to an assistant who was either a nurse anaesthetist or a doctor who prepared the drug as per the group indicated in the chosen envelope while the researcher was blinded. Routine check of the anaesthesia machine, circuits and other equipment was done to ensure functionality, and other drugs were drawn and labelled. Group A received 4 mg of intravenous ondansetron and Group B had 10 mg of intravenous metoclopramide 10 min before induction of anaesthesia. Patients were then wheeled into the operating room and positioned supine on the operating table. A pulse oximeter probe, electrocardiographic leads and blood pressure cuff were applied on the patients and baseline heart rate, peripheral oxygen saturation of haemoglobin (SpO2), and non-invasive blood pressure (BP) were recorded. All patients were pre-oxygenated with 100% oxygen for 3 min followed by a 'sleep dose' of 2.5% sodium thiopentone at 4 mg/kg. After the loss of eyelash reflex, mask ventilation was tested on all patients to confirm ease of ventilation after which 0.5 mg/kg atracurium was administered intravenously followed by gentle mask ventilation using 1–2% of isoflurane in 100% oxygen for 2 min. With the patient deeply anaesthetised and well relaxed, laryngoscopy and orotracheal intubation was done with appropriate sized single use portex, cuffed endotracheal tube (ETT). Correct ETT placement was confirmed by chest movement and auscultation as well as capnography and satisfactory SpO2 reading after which the tube was secured with an adhesive tape. All patients were given 0.5 mg/kg of pentazocine intravenously to a maximum dose of 30 mg for analgesia. Anaesthesia was maintained with 33% oxygen in air using 1–1.5% isoflurane using intermittent positive pressure ventilation (IPPV) at tidal volume of 7 ml/kg and a rate of 12–16/min as appropriate. Intraoperative monitoring included continuous ECG, capnography, temperature, pulse oximetry, and non-invasive blood pressure measurements at 5-min intervals. At the end of the procedure, isoflurane was cut off and residual neuromuscular blockade was reversed with 0.02 mg/kg atropine and 0.04 mg/kg neostigmine administered intravenously. All patients were extubated awake after satisfactory spontaneous ventilation, obeying command, sustained head lift or a hand grip for 10 s as well as satisfactory vitals. Patients were transferred to the recovery room where monitoring of vital signs continued which include pulse rate, blood pressure and oxygen saturation. All patients were given an IV infusion of 1 g paracetamol.
Data collected from each patient included age, weight, surgical procedure carried out, duration of surgery, duration of anaesthesia and the time required for the patient to recover from anaesthesic agents which was the first response to spoken command.
Assessment of nausea and vomiting was done by direct questioning after recovery from anaesthesia in the immediate postoperative period at 10 min of arrival in the recovery room, 30 min, 1 h, 2 h thereafter, and at intervals of 1 h for 4 h in the ward. Nausea was defined as a subjectively unpleasant feeling associated with the awareness and urge to vomit, and vomiting was defined as the forceful expulsion of gastric contents from the mouth. Nausea was graded as mild when it lasted for less than 2 h and severe if for more than 2 h. Vomiting was assessed by recording the number of vomiting bouts.
Side effects of drugs sought were headache, drowsiness and tremors every 30 min. Patients with nausea were reassured and given intravenous fluids if it persisted for more than 2 h. Patients who experienced vomiting were treated with 4 mg of intravenous ondansetron as rescue antiemetic after two bouts of vomiting.
Data was analysed using Statistical Package for Social Sciences (SPSS) version 16.0 Chicago, IL for windows. Summary statistics were done using means, standard deviations, frequency and percentages and the results presented in the form of tables and charts. Student's test was used for analysis of continuous variables and Chi-square test for categorical variables. P < 0.05 was regarded significant.
| Results|| |
Sixty-six patients were evaluated in two treatment groups. The patients' characteristics, duration of anaesthesia, surgery and recovery time were not significantly different statistically in the two groups [Table 1] and [Table 2].
[Figure 1] is a comparison of the frequencies of nausea and vomiting in the two groups. Nausea occurred in 11 patients (33.3%) in the metoclopramide group and 5 (15.2%) in the ondansetron group (P = 0.001). Three patients (9.1%) vomited in the metoclopramide group and 1 (3%) in the ondansetron group (P< 0.0001).
|Figure 1: Comparison of incidence of nausea and vomiting (PONV) in the treatment groups|
Click here to view
The severity of PONV varied in the two groups. Eight patients (24.2%) experienced mild nausea in the metoclopramide group whereas 3 patients (9.1%) experienced severe nausea. Two patients (6.1%) developed mild nausea in the ondansetron group and 3 (9.1%) had severe nausea (P = 0.2) [Table 3]. Two patients (6.1%) in the metoclopramide group experienced 1 bout of vomiting each whereas only 1 (3%) in the ondansetron group had an episode of vomiting. One patient (3%) in the metoclopramide group experienced two bouts of vomiting, none in the ondansetron group had up to 2 bouts of vomiting (P = 0.5) [Table 4].
| Discussion|| |
Ondansetron is a potent and selective 5HT3 receptor antagonist, and our patients represent a high-risk group. Our findings reaffirm the superiority of ondansetron over metoclopramide in the prevention of PONV which compares favourably with studies conducted with same agents under similar settings. Kulsoom et al. studied patients who underwent laparoscopic cholecystectomy and reported a remarkably lower incidence of PONV (11.8%) with ondansetron prophylaxis compared to 42.4% with metoclopramide. Raphael et al. got a much higher percentage of prevention (82%) with ondansetron in patients who underwent day-case gynaecological laparoscopic procedures. Usha et al. in addition to ondansetron and metoclopramide also studied granisteron used alone, and in combination with dexamethasone for PONV in day-case laparoscopic gynaecological surgery. PONV was prevented in 63.3% and 66.7% in the ondansetron and granisetron groups, respectively, whereas metoclopramide was less effective with 36.7% prevention. Addition of dexamethasone showed an improvement of about 30% in the groups. It is important to note that Usha used tramadol and nitrous oxide which might have elevated the risk of PONV but did not influence the trend in outcome.
In a study from southwest Nigeria, Kushimo and Okeke  reported a similar incidence of vomiting when they compared ondansetron with promethazine for prophylaxis against PONV during gynaecological procedures with corresponding incidences of 12% and 60%, respectively. Postoperative drowsiness was however a prominent side effect (32%) in the promethazine group making it less suitable for day-case surgery.
Metoclopramide is a routinely used antiemetic for the prevention of PONV and high incidences have been reported with its use. Banjour et al. compared ondansetron and metoclopramide for prophylaxis of PONV during gynaecological surgery and reported higher figures than our study. They reported incidences of 60% in the metoclopramide group and 47% in the ondansetron group. Their studies had large numbers (380) of patients, and the differences in anaesthetic technique might have been contributory because nitrous oxide was used.
In this study, nausea was mostly of the mild form in the metoclopramide group with 8 patients (24.2%) whereas 3 patients (9.1%) experienced severe nausea; the ondansetron group similarly had 3 patients (9.1%) experiencing severe nausea whereas 2 patients (6.1%) experienced mild nausea (P = 0.2) This suggests that, though the overall incidence of nausea was less in the ondansetron group compared to metoclopramide group, the former did not prevent severe nausea than the later. Conversely, ondansetron was more efficacious in the prevention of the mild form of nausea. This tends to agree with findings in the Kushimo and Okeke  study. However, the difference in this study was not significant.
Both drugs had good safety profiles as the incidence of side effect were minimal. One patient (3%) in the ondansetron group developed headache whereas no side effect was reported in the metoclopramide group which is similar to observations in the study by Awana et al.
We therefore conclude that ondansetron was more effective than metoclopramide in the prevention of nausea in patients undergoing elective day-case gynaecological laparoscopic procedures. Both metoclopramide and ondansetron were effective in the prevention of vomiting but ondansetron still offered superior prophylaxis. There were no significant side effects for both metoclopramide and ondansetron when used as prophylaxis.
We had no control (placebo) group for comparison with the studied antiemetic drugs due to ethical concerns.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]