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

Launched by BENAROYA RESEARCH INSTITUTE · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Barhemsys to see if it can help prevent nausea and vomiting after bariatric surgery, which is a type of weight loss surgery. Researchers want to find out how effective Barhemsys is for patients who might experience these uncomfortable symptoms after their surgery. The study is currently looking for adult participants aged 18 to 65 who are scheduled for specific types of bariatric surgery and will be staying in the hospital for at least one day after their procedure.

To be eligible for the trial, participants should be in good general health (ASA class I-III) and not have certain medical conditions, such as pregnancy, severe kidney issues, or allergies to Barhemsys. Those who take specific medications or have certain health concerns, like Parkinson's disease, will not be able to join. If you participate, you can expect to receive the study medication during your hospital stay and be monitored for any side effects or improvements in your symptoms. This trial aims to improve care for patients undergoing bariatric surgery by reducing the risk of postoperative nausea and vomiting.

Gender

ALL

Eligibility criteria

• 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