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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Post Operative Nausea and Vomiting

In brief

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.

Key facts

Study ID

NCT06585540

Run by

Benaroya Research Institute

People needed

100

Starts

2024-09-13

Expected to finish

2026-01-01

Last updated by the study team

2024-09-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Virginia Mason Medical Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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