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

ConditionPost Operative Nausea and Vomiting

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-65

SponsorBenaroya Research Institute

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

Amisulpride IV Prevention
Amisulpride IV Treatment
Placebo Preventative
Placebo Treatment

Treatment groups

100 Participants

are divided into 4 treatment groups

Sponsors and collaborators

Benaroya Research Institute

Lead sponsor

Virginia Mason Hospital/Medical Center

Collaborator

Source ClinicalTrials.gov