Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06585540

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

Led by Benaroya Research Institute · Updated on 2024-09-26

100

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

B

Benaroya Research Institute

Lead Sponsor

V

Virginia Mason Hospital/Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of Amisulpride to treat and prevent Post Operative Nausea and Vomiting (PONV) in adult patients undergoing bariatric surgery. This phase III/IV randomized, placebo-controlled, patient-blinded crossover pilot study involves adults aged 18 to 65 years at a single surgery site in the Pacific Northwest. The study aims to compare Amisulpride with placebo to understand its role in managing PONV after bariatric procedures. Participants are randomly assigned to receive either a single intravenous dose of Amisulpride (5 mg) or a placebo at the start of anesthesia. Those initially given placebo who experience nausea or vomiting in the post-anesthesia care unit (PACU) undergo a second randomization to receive either a 10 mg dose of Amisulpride or placebo as first-line treatment for PONV. The study includes several types of bariatric surgeries such as robotic, laparoscopic, and open procedures. During the study, patients will be monitored in the PACU for up to 60 to 120 minutes to assess response to treatment. Researchers will track the number of patients achieving complete response, the incidence of nausea and vomiting, use of rescue medications, and other related outcomes up to 24 hours after surgery. This will help evaluate the effectiveness of Amisulpride in preventing and treating PONV. The total duration of participation depends on hospital stay and follow-up within 24 hours post-surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Scheduled for bariatric surgery including Robotic, Laparoscopic, or Open Roux-en-Y, Gastric Sleeve, Gastrectomy, or Revision Gastric Bypass
  • ASA class I-III
  • Planned inpatient stay of at least 24 hours
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Any condition or abnormality that may compromise patient safety or data quality as judged by the Investigator
  • Congenital QTc abnormalities
  • Current use of droperidol
  • Parkinson's disease
  • Allergy to Barhemsys
  • Glomerular filtration rate less than 30 mL/min/1.73m2
  • Emergency surgery or add-on cases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Duration of surgery and immediate recovery (approximately 1 to 2 hours)

Participants receive a single intravenous dose of Amisulpride or placebo at the induction of anesthesia during bariatric surgery. Those who initially receive placebo may receive an additional dose of Amisulpride or placebo in the post-anesthesia care unit as first-line treatment for postoperative nausea and vomiting.

1 surgery visit and 1 post-anesthesia care unit visit

Trial Site Locations

Total: 1 location

1

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Actively Recruiting

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Research Team

J

Justin S Liberman, Medical Doctor

D

David B Auyong, Medical Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

4

Frequently Asked Questions

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Published Research Related To This Trial

Prevalence and Risk Factors for Bariatric Surgery Readmissions: Findings From 130,007 Admissions in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.

Elizabeth R Berger, Kristopher M Huffman, Teresa Fraker...

https://pubmed.ncbi.nlm.nih.gov/27849660

Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Phase III Trial.

Ashraf S Habib, Peter Kranke, Sergio D Bergese...

https://pubmed.ncbi.nlm.nih.gov/30475232

Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis.

Keith A Candiotti, Peter Kranke, Sergio D Bergese...

https://pubmed.ncbi.nlm.nih.gov/31094774

Intravenous Amisulpride Does Not Meaningfully Prolong the QTc Interval at Doses Effective for the Management of Postoperative Nausea and Vomiting.

Gabriel M Fox, Muna Albayaty, Joanna L Walker...

https://pubmed.ncbi.nlm.nih.gov/31913911

A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers.

C C Apfel, E Läärä, M Koivuranta...

https://pubmed.ncbi.nlm.nih.gov/10485781