A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea And Vomiting in the Bariatric Surgery Population
Benaroya Research Institute
100 participants
Sep 13, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria8
- 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
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Interventions
Patients in this arm will receive Amisulpride 5mg IV as a preventative dose after the induction of anesthesia
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.
Patients in this arm will receive placebo (Normal Saline) while under general anesthesia
Patients in this Arm will receive placebo as first line treatment of Post-Operative Nausea and Vomiting in the Post Anesthesia Care Unit
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06585540