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Antiemetic

Amisulpride for Postoperative Nausea and Vomiting

Phase 3

Recruiting

Led By Justin S Liberman, Medical Doctor

Research Sponsored by Benaroya Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until patient leaves post anesthesia care unit (60-120 minutes)

Awards & highlights

Pivotal Trial

Summary

"This trial aims to test if Amisulpride is effective in treating nausea and vomiting after surgery, and if it can prevent these symptoms after bariatric surgery."

Who is the study for?

Adults aged 18-65 scheduled for bariatric surgery (like gastric bypass or sleeve gastrectomy) can join this study. They should be in good enough health for surgery (ASA class I-III) and plan to stay in the hospital at least a day after.

What is being tested?

The trial is testing Amisulpride, given through an IV, against a placebo to see if it can prevent or treat nausea and vomiting after weight-loss surgery. Participants will randomly receive either the drug or placebo.

What are the potential side effects?

Amisulpride may cause side effects like restlessness, increased prolactin levels leading to menstrual changes or sexual dysfunction, low blood pressure, and potential heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had or am planning to have weight loss surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until patient leaves post anesthesia care unit (60-120 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until patient leaves post anesthesia care unit (60-120 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until patient leaves post anesthesia care unit (60-120 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With "Complete Response" in the Post Anesthesia Care Unit

Secondary study objectives

Incidence of complete response to established Post-operative Nausea and Vomiting

Number of Participants With no Use of Rescue Medication

Number of Participants with no Emesis

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Group Placebo BarhemsysExperimental Treatment1 Intervention

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

Group II: Group BarhemsysExperimental Treatment1 Intervention

Interventional arm receiving Barhemsys during surgery

Group III: Group PlaceboPlacebo Group1 Intervention

Placebo arm receiving Placebo during surgery

Group IV: Group Placebo PlaceboPlacebo Group1 Intervention

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

0 / 1Eligibility criteria met