NCT06585540PHASE3RecruitingAccepts Healthy Volunteers

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

Benaroya Research Institute

Start Date

9/13/2024

Completion Date

1/1/2026

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.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * The study will recruit adult patients (Age 18-65) scheduled for bariatric surgery. Additional inclusion criteria include ASA class I-III and patients who plan to be inpatient for at least 24 hours. Included Surgeries: Robotic, Laparoscopic or Open Roux-en-Y Robotic, Laparoscopic or Open Gastric Sleeve Robotic, Laparoscopic or Open Gastrectomy Robotic, Laparoscopic or Open Revision Gastric Bypass Exclusion Criteria: * Pregnant or breastfeeding * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. * Congenital QTc abnormalities * Current use of droperidol * Parkinson's disease * Allergy to Barhemsys * GFR \< 30 mL/min/1.73m2 * Emergency surgery or add-on cases

Interventions

DRUG

Amisulpride IV Prevention

DRUG

Amisulpride IV Treatment

DRUG

Placebo Preventative

DRUG

Placebo Treatment

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Conditions

Post Operative Nausea and Vomiting

Locations

Virginia Mason Medical Center

Seattle, Washington 98101

United States