Pilot Study of Amisulpride Barhemsys to Prevent and Treat Postoperative Nausea and Vomiting in Adults Undergoing Bariatric Surgery

What this Trial Is About

Researchers are evaluating the effectiveness of Amisulpride to treat and prevent Post Operative Nausea and Vomiting PONV in adult patients undergoing bariatric surgery. This phase IIIIV randomized, placebo-controlled, patient-blinded crossover pilot study involves adults aged 18 to 65 years at a single surgery site in the Pacific Northwest. The study aims to compare Amisulpride with placebo to understand its role in managing PONV after bariatric procedures. Participants are randomly assigned to receive either a single intravenous dose of Amisulpride 5 mg or a placebo at the start of anesthesia. Those initially given placebo who experience nausea or vomiting in the post-anesthesia care unit PACU undergo a second randomization to receive either a 10 mg dose of Amisulpride or placebo as first-line treatment for PONV. The study includes several types of bariatric surgeries such as robotic, laparoscopic, and open procedures. During the study, patients will be monitored in the PACU for up to 60 to 120 minutes to assess response to treatment. Researchers will track the number of patients achieving complete response, the incidence of nausea and vomiting, use of rescue medications, and other related outcomes up to 24 hours after surgery. This will help evaluate the effectiveness of Amisulpride in preventing and treating PONV. The total duration of participation depends on hospital stay and follow-up within 24 hours post-surgery.

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