Palonosetron vs. Ondansetron for Postoperative Nausea and Vomiting in Bariatric Surgery

Completed

• Conditions: Pain, Postoperative; Patient Reported Outcomes; Vomiting, Postoperative; Antiemetics; Nausea, Postoperative
• Interventions: Procedure: Laparoscopic sleeve gastrectomy; Drug: Ondansetron 1 mg/kg, max dose 8 mg; Drug: Palonosetron 1mcg/kg

• Registration Number: NCT04533867
• Lead Sponsor: Bagcilar Training and Research Hospital

Brief Summary

Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.

Detailed Description

Postoperative nausea and vomiting (PONV) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. In recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of PONV in bariatric surgery. In this study, the effects of ondansetron and palonosetron on PONV in patients who undergo sleeve gastrectomy will be compared.

Study Timeline

• Study First Submitted: 2020-08-09
• Study Start: 2020-08-15
• Study First Submitted QC: 2020-08-29
• Study First Posted: 2020-09-01
• Primary Completion: 2020-12-15
• Status Verified: 2021-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All morbidity obese patients underwent laparoscopic sleeve gastrectomy

Exclusion Criteria

drug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-HT3 antagonists, emergency surgeries and chemotherapy within.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron 1 mg/kg, max dose 8 mg	In Group B (n = 50): Intravenous injection of ondansetron 0.1 mg/kg diluted up to 5 mL with normal saline solution in a maximum dose of 8 mg is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.
Palonosetron	Palonosetron 1mcg/kg	The antiemetics used are palonosetron in Group A (n = 50): Intravenous injection of Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.
Ondansetron	Laparoscopic sleeve gastrectomy	In Group B (n = 50): Intravenous injection of ondansetron 0.1 mg/kg diluted up to 5 mL with normal saline solution in a maximum dose of 8 mg is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.
Palonosetron	Laparoscopic sleeve gastrectomy	The antiemetics used are palonosetron in Group A (n = 50): Intravenous injection of Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.

Primary Outcome Measures

Name	Time	Method
Nause and vomiting 24hr	postoperative 24 hours	Visual Analog Scale score for nausea and vomiting
Nause and vomiting 48hr	postoperative 48 hours	Visual Analog Scale score for nausea and vomiting
Nause and vomiting 6hr	postoperative 6 hours	Visual Analog Scale score for nausea and vomiting
Nause and vomiting 72hr	postoperative 72 hours	Visual Analog Scale score for nausea and vomiting
amount of rescue anti-emetic drugs	postoperative seventh day	Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week.

Secondary Outcome Measures

Name	Time	Method
Pain 72hr	postoperative 72 hours	Visual Analog Scale score for pain
Pain 48hr	postoperative 48 hours	Visual Analog Scale score for pain
Pain 6hr	postoperative 6 hours	Visual Analog Scale score for pain
Pain 24hr	postoperative 24 hours	Visual Analog Scale score for pain

Trial Locations

Locations (2)

Bagcılar Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Surp Pırgic Armenian Hospital; 🇹🇷 Istanbul, Turkey