Evaluating Amisulpride for preventing nausea after bariatric surgery
A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea And Vomiting in the Bariatric Surgery Population
This study is testing if Amisulpride can help prevent nausea and vomiting after bariatric surgery for adults aged 18 to 65.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Benaroya Research Institute Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06585540 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the effectiveness of Amisulpride in preventing and treating postoperative nausea and vomiting (PONV) in adults undergoing bariatric surgery. It is a phase III/IV, randomized, placebo-controlled, patient-blinded crossover study conducted at a single site in the Pacific Northwest. Approximately 100 patients aged 18-65 will be randomized to receive either Amisulpride or a placebo at the start of anesthesia, with additional treatment options provided in the post-anesthesia care unit if needed.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 scheduled for inpatient bariatric surgery with ASA class I-III.
Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions such as Parkinson's disease or congenital QTc abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postoperative nausea and vomiting in bariatric surgery patients, improving their recovery experience.
How similar studies have performed: Other studies have shown promise in using similar approaches for managing PONV, but this specific application of Amisulpride is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seattle, Washington
- Virginia Mason Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Justin S Liberman, Medical Doctor — Virginia Mason Medical Center
- Study coordinator: Justin S Liberman, Medical Doctor
- Email: justin.liberman@vmfh.org
- Phone: 206-341-1298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.