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

Benaroya Research Institute

Status and phase: Enrolling; Phase 3

Conditions: Post Operative Nausea and Vomiting

Treatments: Drug: Placebo Treatment; Drug: Placebo Preventative; Drug: Amisulpride IV Treatment; Drug: Amisulpride IV Prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT06585540

CRP23057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 be inpatient 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 criteria

• 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
• Parkinson's disease
• Allergy to Barhemsys
• GFR < 30 mL/min/1.73m2
• Emergency surgery or add-on cases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

100 participants in 4 patient groups, including a placebo group

Group Barhemsys

Experimental group

Description:

Interventional arm receiving Barhemsys during surgery

Treatment:

Drug: Amisulpride IV Prevention

Group Placebo

Placebo Comparator group

Description:

Placebo arm receiving Placebo during surgery

Treatment:

Drug: Placebo Preventative

Group Placebo Barhemsys

Experimental group

Description:

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

Treatment:

Drug: Amisulpride IV Treatment

Group Placebo Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Treatment