Granisetron Versus Ondansetron for Prevention of Post-operative Nausea and Vomiting (PONV) in Patients Undergoing Laparoscopic Cholecystectomy

DOI: 10.9734/JPRI/2021/v33i54B33759 Editor(s): (1) Dr. Giuseppe Murdaca, University of Genoa, Italy. Reviewers: (1) Joe Liu, Michigan State University, USA. (2) Nazia Nazirc, Government Institute of Medical Sciences, India. (3) Anjali R, AIIMS, India. Complete Peer review History, details of the editor(s), Reviewers and additional Reviewers are available here: https://www.sdiarticle5.com/review-history/77774


INTRODUCTION
PONV leads to serious surgical complications like wound dehiscence, surgical site bleeding which result in delayed wound healing and prolong hospital stay ultimately lead to increase burden over country's economy [1]. The Postoperative nausea and vomiting (PONV) are common sequelae of general anaesthesia and a leading cause of delayed discharge and unanticipated hospital admission after ambulatory surgical procedures [2]. A lot of drugs have been used for prevention of PONV. Most act as antagonist at the receptors which are involved in emesis. The traditional antiemetics include antihistamines, anticholinergics and dopamine-receptor antagonists [3]. Newer drugs like Serotonin Receptor Antagonists (granisetron and ondansetron) provide better efficacy and safety as compared to the traditional drugs [4]. They bind to the 5-Hydroxytryptamine subtype-3 (5HT3) receptors, selectively blocking the emetogenic stimuli during anesthesia and surgery. They have proven efficacy and is recommended as a prophylactic antiemetic at the time of induction of anesthesia [5]. Further, the combination of 5HT3 receptor antagonists with dexamethasone has better control of PONV than administration of single drug therapy in high risk cases [6]. In a recent study conducted at India, observed that granisetron better than ondansetron as a prophylaxis against PONV following laparoscopic procedures, with incidence of nausea 36% in Group O and 12% in Group G, which was significantly low [7]. Another researcher revealed that the frequency for need of overall rescue antiemetics were more in Group The rationale of study was to determine the use of Granisetron versus ondansetron as more effective antiemetic drug in terms of reduced number of emetic episodes, for prevention of PONV in our setting, where no such study had been conducted so in our country. Although the mode of action of both drugs is same but one better drug in preventing PONV reduce the hospital stay and thereby reduce the cost during post-operative care.

MATERIALS AND METHODS
This study was conducted for the time period of six months from June 2018 to November 2018 at department of Anaesthesia and SICU, PUMHSW, Sindh, Pakistan. 100 those patients were included in this study who give their written consent with age 20-60 years of both sexes and ASA type I and II while those patients have history of motion sickness, previous exposure to general anesthesia, pregnancy, menstruation, upper gastro intestinal disease and taken antiemetic drugs pre operatively within 24 hours of operation were excluded from this study. Patients were randomly allocated into two cohorts, G & O for each drug, each group consisting of 50 patients. Cohort G received granisetron 1 mg I/V before induction whereas Cohort O received ondansetron 4 mg I/V before induction.
Research instrument was predesigned proforma, which incorporate clinical examination, relevant laboratory investigations, ASA score and postoperative outcome/ nausea & vomiting according to study design. All patients were kept nil by mouth for 8 hours before surgery.
All the patients were re-examined and assessed preoperatively in the operating room. Intravenous (I/V) access was established with an 18G I/V cannula and for Premedication inj. Alprazolam 0.1mg/kg, inj. Ranitidine 50mg,inj. Glycopyrolate 0.2mg I/V was used and for analgesia inj. acetaminophen 10mg/kg infusion and inj. ketarolac 30mg diluted I/V was used. All monitoring equipments like pulse oximeter, noninvasive blood pressure &ECG monitors were checked and applied to each patient on arrival to the operating room.
Induction of anesthesia done with Inj. Propofol 2 mg/kg, Inj. Succinylcholine 1.5 mg/kg. Inj. Nalbuphine 0.1 mg/kg I/V were used for analgesia and inj. atracurium 0.5 mg/kg I/V were used to provide maintenance of muscle relaxation during surgery depending on the type and duration of the procedure.
Maintenance of anesthesia done isoflurane 1.20% and Oxygen mixture using controlled ventilation. On completion of surgery, the residual paralysis was reversed with Inj. Neostigmine 0.035 mg/kg I/V and glycopyrrolate 0.01 mg/kg IV. Patients were transported to the recovery room and later to the ward after confirming an adequate level of consciousness and intact reflexes. Postoperative analgesia was given with acetaminophen infusion 10mg/kg I/V 6 hourly& inj.ketarolac 30 mg bid.
The PONV cases were recorded within the first 24 hours after surgery at intervals of 0-2 hours, 3 hours, 6 hours, 12 hours and 24 hours. Episodes of PONV were identified by spontaneous complaints by the patients or by direct questioning. "Complete response" was defined as the absence of nausea or vomiting and no need for rescue anti-emetics during the 24-hour observation period. Whenever any of the intervention drug under study fails to prevent PONV, the rescue antiemetic single dose were provided with Inj. Metoclopramide 10 mg and Inj. Dexamethasone 8 mg I/V after event of 1 st episodes of nausea or vomiting.
The results were analyzed by using latest SPSS-21 version and level of significance was kept at p-value ˂0.05.

RESULTS
A total of 100 patients were included in this study. Patients were randomly divided into two groups. Cohort G received granisetron 1 mg I/V before induction whereas Cohort O received ondansetron 4 mg I/V before induction. Each group contains 50 patients. Regarding frequency of post operative complications (PONV) there was no significant difference between efficacies of granisetron and ondansetron groups as pvalue is found to be ≤0.05.
The patient were distributed by their age and gender.

Results are presented as n (%) Chi-Square test applied
The patients of both groups were also distributed according to ASA status.
PONV within 1 hour, PONV after1 hour. PONV after 2 hour, PONV after 3 hour, PONV after 6 hour, PONV after 12 hour and PONV after 24 hour is shown in Table. Demographic variables distribution of the patients is presented in Figures where as Table 1 is showing post operative complications among groups.

DISCUSSION
A total of 100 patients were included in this study. Regarding complications there was not significant difference between efficacy of granisetron and ondansetron groups as the value was found to be ≤0.  The occurrence of nausea and vomiting and the severity of nausea according to avisual analogue scale were monitored immediately after the end of surgery and during the following 24 h. The incidence of PONV was significantly lower in the palonosetron group compared with the ondansetron group (42.2% vs 66.7%,respectively). There were no significant statistical differences for PONV similar to present study. In conclusion, palonosetron 0.075 mg was more effective than ondansetron 8 mg in preventing PONV.

CONCLUSION
Our results showed that Group G and group O regarding frequency of post operative complications (PONV) showed insignificant results as no value is found to be ≤0.05.

DISCLAIMER
The products used for this research are commonly and predominantly use products in our area of research and country. There is absolutely no conflict of interest between the authors and producers of the products because we do not intend to use these products as an avenue for any litigation but for the advancement of knowledge. Also, the research was not funded by the producing company rather it was funded by personal efforts of the authors.

CONSENT
All authors declare that 'written informed consent was obtained from the patient.

ETHICAL APPROVAL
As per international standard or university standard written ethical approval has been collected and preserved by the authors.