A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population
NCT Number: NCT06585540
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Post Operative Nausea and Vomiting
Sponsor: Benaroya Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-09-09
Completion Date: 2026-01

Summary:
The purpose of this study is to evaluate the drug, Barhemsys (Amisulpride), on Postoperative Nausea and Vomiting following Bariatric surgery. Postoperative nausea and vomiting is any nausea or vomiting that occurs within 24 hours following surgery.

Barhemsys is approved for the treatment and prevention of Postoperative Nausea and Vomiting in the United States by the U.S. Food and Drug Administration (FDA).

You are being asked to take part in this study because you are going to receive anesthesia and nausea medication for your bariatric surgery. General anesthesia is used to put a person in a deep sleep, so they do not feel pain during surgery.

If you choose not to participate in the study, you and your doctor will discuss which nausea medications will be provided to you under general anesthesia. If you do participate in the study, you will be randomly assigned (like flipping a coin) into one of two groups, but you won't be told which group you are in:

* Group A will receive anesthesia and nausea medications that include dexamethasone, ondansetron, propofol and the study drug, Barhemsys
* Group B will receive anesthesia and nausea medications that include dexamethasone, ondansetron, and propofol. Group B patients will not receive Barhemsys during anesthesia. Instead, Group B will receive a placebo. A placebo is a substance that is made to look like a drug but has no drug in it. This is so that no one knows you are in Group B.

If you have Nausea after your surgery and you are in Group B, you may receive Barhemsys as a treatment or an additional placebo treatment. Half of group B is expected to receive Barhemsys and half will receive Placebo. If you continue to have nausea you will be provided additional medication to treat your symptoms. You will not be denied medications that are part of the standard of care for treating nausea following surgery.

If you participate in this study, researchers will:

Evaluate your medical history to make sure you are eligible to participate. Randomly assign you to either the group receiving anesthesia with Barhemsys or to the group receiving anesthesia without Barhemsys Collect information about your health before, during and after your bariatric surgery.

Collect information about your nausea and the nausea medications you are prescribed as part of your normal care after your surgery.

Your direct participation is expected to last for 24 hours after your surgery. Researchers may continue to access your medical records to follow how you are doing and audit data.

Risks:

All general anesthetics have some risk of reaction to medications given. Barhemsys is part of a class of medications that can cause chills, low potassium, low blood pressure or abdominal distension.

Patients in the placebo group may experience more nausea. There is a risk of loss of confidentiality of your information. You will read about the steps we take to help keep your information private and secure later in this form.

If you agree to take part in this study, and receive the study drug, Barhemsys, there may be a direct benefit to you as the study drug may be more effective at treating post surgery nausea and vomiting following bariatric surgery. We hope the information learned from this study will benefit other people who undergo Bariatric Surgery in the future.

Taking part in this study is voluntary, and you may choose not to take part or may leave the study at any time. Choosing not to take part or leaving the study will not result in any penalty or loss of benefits to which you are entitled outside of this research.

Primary Outcome Measures: Number of Participants With "Complete Response" in the Post Anesthesia Care Unit, Complete response is defined as no occurrence of vomiting or retching, no nausea score ≥ 1 and no use of rescue medication during their Post Anesthesia Care Unit stay., Until Patient Leaves Post Anesthesia Care Unit (60-120 minutes)
Secondary Outcome Measures: Incidence of complete response to established Post-operative Nausea and Vomiting, Effectiveness of Barhemsys in the treatment of established nausea or vomiting in the high-risk bariatric surgical population during Post Anesthesia Care Unit stay. Failure of complete response is defined as subject emesis or use of rescue medication during Post Anesthesia Care Unit stay following a treatment dose of Barhemsys., Until Patient leave Post Anesthesia Care Unit (60-90 minutes)|Number of participants with no nausea, Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No nausea" means no score ≥ 1., Up to 24 hours following surgery|Number of Participants with no Emesis, Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach), Up to 24 hours following surgery|Number of Participants With no Use of Rescue Medication, Any agent given in the post-operative period with the intention of providing anti-emetic rescue is counted as rescue antiemetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the postoperative period which would be expected, by virtue of its pharmacology, dosage, and route, to exert a clinically meaningful antiemetic effect was considered as rescue antiemetic medication, even if administered inadvertently or without the intention of providing rescue., Up to 24 hours following surgery|The Number of Participants With no Emesis, no Significant Nausea, and no Use of Rescue Medication, No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication., Up to 24 hours following surgery|The Number of Participants With no Significant Nausea, Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No significant nausea" means no score ≥ 4., Up to 24 hours following surgery