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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Benaroya Research Institute
Study ID
NCT06585540
Phase
PHASE3
Status
Recruiting
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Conditions

  • Post Operative Nausea and Vomiting

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Amisulpride IV Prevention — DRUG
    Patients in this arm will receive Amisulpride 5mg IV as a preventative dose after the induction of anesthesia
  • Amisulpride IV Treatment — DRUG
    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.
  • Placebo Preventative — DRUG
    Patients in this arm will receive placebo (Normal Saline) while under general anesthesia
  • Placebo Treatment — DRUG
    Patients in this Arm will receive placebo as first line treatment of Post-Operative Nausea and Vomiting in the Post Anesthesia Care Unit

Study Details

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 Dates

Start date
Sep 13, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Group Barhemsys
    Interventional arm receiving Barhemsys during surgery
  • Placebo Comparator: Group Placebo
    Placebo arm receiving Placebo during surgery
  • Experimental: Group Placebo Barhemsys
    Of patients who are members of Group Placebo they will be able to receive Barhemsys in the Post Anesthesia Care Unit if they experience nausea or emesis
  • Placebo Comparator: Group Placebo Placebo
    Of patients who are members of Group Placebo they will be able to receive Placebo in the Post Anesthesia Care Unit if they experience nausea or emesis

Primary Outcome Measure

Number of Participants With "Complete Response" in the Post Anesthesia Care Unit [ Time Frame: Until Patient Leaves Post Anesthesia Care Unit (60-120 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Mason Medical CenterSeattleWashington98101
Justin S Liberman, MD MPH
[email protected]
206-341-1298
David B Auyong, MD
[email protected]
206-341-1298
Justin S Liberman, MD (PRINCIPAL_INVESTIGATOR)
David B Auyong, MD (SUB_INVESTIGATOR)

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By research site
Virginia Mason Medical Center· Seattle, WA