NCT06585540

A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea And Vomiting in the Bariatric Surgery Population

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Benaroya Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To assess the effectiveness of Amisulpride to treat Post Operative Nausea and Vomiting (PONV) and to assess the effectiveness of Amisulpride to prevent PONV following bariatric surgery.

Detailed description

This is a phase III/IV, randomized, placebo-controlled, patient-blinded cross-over pilot study to evaluate the effectiveness of Amisulpride in the treatment and prevention of Post Operative Nausea and Vomiting (PONV) in adult patients, 18-65 years of age, at a single surgery site in the pacific northwest who are undergoing bariatric surgery. Approximately 100 patients will be randomized in a 1:1 ratio to receive a single intravenous dose of Amisulpride (5mg IV single dose) or a placebo (saline control, 1mL IV single dose) at the induction of anesthesia. Those who initially receive placebo will undergo an additional randomization in the post-anesthesia care unit (PACU) to receive a dose of Amisulpride (10mg IV single dose) or placebo (saline control, 2mL IV single dose) in a 1:1 ratio as first line treatment for PONV.

Conditions

• Post Operative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Amisulpride IV Prevention	Patients in this arm will receive Amisulpride 5mg IV as a preventative dose after the induction of anesthesia
DRUG	Amisulpride IV Treatment	Patients in this arm will receive Amisulpride 10mg IV for first-line treatment of Post-Operative Nausea and Vomiting in the post-anesthesia care unit.
DRUG	Placebo Preventative	Patients in this arm will receive placebo (Normal Saline) while under general anesthesia
DRUG	Placebo Treatment	Patients in this Arm will receive placebo as first line treatment of Post-Operative Nausea and Vomiting in the Post Anesthesia Care Unit

Timeline

• Start date: 2024-09-13
• Primary completion: 2025-09-01
• Completion: 2026-01-01
• First posted: 2024-09-05
• Last updated: 2024-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study