Status:
RECRUITING
A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population
Lead Sponsor:
Benaroya Research Institute
Collaborating Sponsors:
Virginia Mason Hospital/Medical Center
Conditions:
Post Operative Nausea and Vomiting
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06585540
Start Date
September 13 2024
End Date
January 1 2026
Last Update
September 26 2024
Active Locations (1)
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1
Virginia Mason Medical Center
Seattle, Washington, United States, 98101