Recruiting
Phase 3

Barhemsys

Sponsor:

Benaroya Research Institute

Code:

NCT06585540

Conditions

Post Operative Nausea and Vomiting

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Amisulpride IV Prevention

Amisulpride IV Treatment

Placebo Preventative

Placebo Treatment

Study Details

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.

Conditions

Post Operative Nausea and Vomiting

Study ID

NCT06585540

Start date

Sep 13, 2024

Status verified date

Sep, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Amisulpride IV Prevention

Patients in this arm will receive Amisulpride 5mg IV as a preventative dose after the induction of anesthesia

Amisulpride IV Treatment

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

Patients in this arm will receive placebo (Normal Saline) while under general anesthesia

Placebo Treatment

Patients in this Arm will receive placebo as first line treatment of Post-Operative Nausea and Vomiting in the Post Anesthesia Care Unit

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 and Locations

Central contacts

Justin S Liberman, Medical Doctor

206-341-1298justin.liberman@vmfh.org

David B Auyong, Medical Doctor

206-341-1298David.Auyong@vmfh.org

Locations

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Justin S Liberman, MD MPH

206-341-1298justin.liberman@vmfh.org

David B Auyong, MD

206-341-1298David.Auyong@vmfh.org

More Information

Sponsor

Benaroya Research Institute

Last update posted

Sep 26, 2024

Last verified

Sep, 2024

Keywords

  • Post Operative Nausea and Vomiting
  • Bariatric Surgery
  • Bariatric
  • Barhemsys
  • Amisulpride

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benaroya Research Institute on 2024-09-26.