Amisulpride for Postoperative Nausea and Vomiting
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called amisulpride (Amisulpride Injection [Barhemsys]) to determine if it can prevent nausea and vomiting after surgery in children. It focuses on children undergoing non-emergency surgeries, such as eye surgery or ear and throat procedures. The trial divides participants into two groups, each receiving different doses of amisulpride along with dexamethasone. Suitable candidates are children having these surgeries under general anesthesia, not using certain other specific medications, and without certain medical conditions like dizziness or allergies to the drugs being tested. As a Phase 2, Phase 3 trial, this research evaluates the treatment's effectiveness and represents the final step before FDA approval, offering participants a chance to contribute to important medical advancements.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot be on regular anti-emetic therapy or certain medications like levodopa. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that amisulpride, sold as Barhemsys, is approved for adults to prevent nausea and vomiting after surgery, indicating thorough safety testing in adults. In these studies, amisulpride was generally well-tolerated, with common mild side effects like dizziness and headache, while serious side effects were rare.
In this trial, children receive amisulpride at two different doses, along with dexamethasone, which reduces inflammation and prevents nausea. Since amisulpride is already used safely in adults, this offers some reassurance about its safety. However, because this trial is in an earlier stage, monitoring for any new side effects in children is crucial. Researchers will closely monitor participants to ensure their safety.12345Why are researchers excited about this trial's treatments?
Most treatments for postoperative nausea and vomiting (PONV) focus on blocking specific receptors tied to vomiting, like serotonin or histamine. But Amisulpride, the study drug, works differently by blocking dopamine receptors, offering a fresh angle for tackling PONV. Researchers are excited because this unique mechanism might help patients who don't respond well to existing options. Moreover, the combination with dexamethasone could potentially enhance its effectiveness, providing a more robust solution for managing PONV.
What evidence suggests that amisulpride might be an effective treatment for postoperative nausea and vomiting?
Research has shown that amisulpride helps prevent nausea and vomiting after surgery. In this trial, participants will receive amisulpride through an IV in combination with dexamethasone. Studies have found that IV amisulpride works well both on its own and with other medications. Specifically, trials comparing it to a placebo (a substance with no active drug) showed that patients who received amisulpride experienced significantly less nausea and vomiting. These patients had fewer episodes of nausea, highlighting the medication's potential benefits. Therefore, amisulpride has a strong record in managing these symptoms after surgery.56789
Who Is on the Research Team?
Kumar Belani, MD
Principal Investigator
University of Minnesota Masonic Children's Hospital
Are You a Good Fit for This Trial?
This trial is for children from birth to 17 years old who are having non-emergency surgeries like eye surgery, adenotonsillectomy, or otoplasty. They must be healthy enough for anesthesia (ASA I-III) and girls able to have babies must use strong contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IV amisulpride and IV dexamethasone to prevent post-operative nausea and vomiting
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and ECG abnormalities
What Are the Treatments Tested in This Trial?
Interventions
- Amisulpride Injection [Barhemsys]
Amisulpride Injection [Barhemsys] is already approved in United States for the following indications:
- Prevention of postoperative nausea and vomiting (PONV)
- Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different pharmacologic class or have not received prophylaxis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acacia Pharma Ltd
Lead Sponsor
Premier Research
Collaborator
Amicus CD LLC
Collaborator
Premier Research Group plc
Industry Sponsor
John Ratliff
Premier Research Group plc
Chief Executive Officer since 2024
MBA
Dr. Milena Kanova-Petrova
Premier Research Group plc
Chief Medical Officer since 2024
MD