NCT04533867

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

Comparison of Palonosetron and Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Bagcilar Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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.

Conditions

• Nausea, Postoperative
• Vomiting, Postoperative
• Patient Reported Outcomes
• Pain, Postoperative
• Antiemetics

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic sleeve gastrectomy	Sleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape
DRUG	Palonosetron 1mcg/kg	Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.
DRUG	Ondansetron 1 mg/kg, max dose 8 mg	Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.

Timeline

• Start date: 2020-08-15
• Primary completion: 2020-12-15
• Completion: 2021-01-01
• First posted: 2020-09-01
• Last updated: 2021-01-22

Locations

2 sites across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study