NCT05772676

The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastric Sleeve Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Hospital General Tlahuac · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen

Detailed description

After being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to Aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery). The standard antiemetic regimen will be Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg

Conditions

• Obesity
• Nausea and Vomiting, Postoperative

Interventions

Type	Name	Description
DRUG	Aprepitant	80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery
OTHER	Placebo	Placebo + standard antiemetic regimen, once two hours before surgery

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-01-01
• Completion: 2023-04-01
• First posted: 2023-03-16
• Last updated: 2023-03-16

Locations

1 site across 1 country: Mexico