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

Last updated: September 24, 2024
Sponsor: Benaroya Research Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Vomiting

Lactose Intolerance

Colic

Treatment

Placebo Treatment

Amisulpride IV Treatment

Placebo Preventative

Clinical Study ID

NCT06585540
CRP23057
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 beinpatient 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

Exclusion Criteria:

  • Pregnant or breastfeeding

  • Presence of a condition or abnormality that in the opinion of the Investigator wouldcompromise 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

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Placebo Treatment
Phase: 3
Study Start date:
September 13, 2024
Estimated Completion Date:
January 31, 2026

Study 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 Vomiting (PONV) in adult patients, 18-65 years of age, at a single surgery site in the pacific northwest who are undergoing bariatric surgery. Approximately 100 patients will be randomized in a 1:1 ratio to receive a single intravenous dose of Amisulpride (5mg IV single dose) or a placebo (saline control, 1mL IV single dose) at the induction of anesthesia. Those who initially receive placebo will undergo an additional randomization in the post-anesthesia care unit (PACU) to receive a dose of Amisulpride (10mg IV single dose) or placebo (saline control, 2mL IV single dose) in a 1:1 ratio as first line treatment for PONV.

Connect with a study center

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Active - Recruiting

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