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

NCT06585540 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-09-26

No results posted yet for this 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.

Conditions

  • Post Operative Nausea and Vomiting

Interventions

DRUG

Amisulpride IV Prevention

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

DRUG

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.

DRUG

Placebo Preventative

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

DRUG

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

Sponsors & Collaborators

  • Virginia Mason Hospital/Medical Center

    collaborator OTHER

  • Benaroya Research Institute

    lead OTHER

Principal Investigators

  • Justin S Liberman, Medical Doctor · Virginia Mason Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-13
Primary Completion
2025-09-30
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06585540 on ClinicalTrials.gov