NCT07539623PHASE3Recruiting
Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
Icahn School of Medicine at Mount Sinai
Start Date
5/1/2026
Completion Date
12/22/2026
Summary
This is prospective, randomized study. The purpose of this study is to evaluate whether the addition of Suzetrigine to well established multimodal pain regimen for participants undergoing bariatric patients undergoing weight-loss surgery and cardiac patients undergoing sternotomy will reduce post-operative opioid consumption and pain scores.
Eligibility Criteria
Age Range: 18 years to 85 years
Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
* Adults 18-85 years old
* Scheduled to undergo cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)
* All genders
Exclusion Criteria:
Any individual who meets any of the following criteria will be excluded from participation in this study:
* ASA Class V
* Urgent or emergent surgery
* Contraindications to administration of Suzetrigine (e.g. concomitant use of strong CYP3A inhibitors)
* History of substance use disorder or chronic opioid use
* Reoperation
* Patient refusal or inability to consent
* Patients who take moderate-to-severe CYP3A inhibitors (such as Ritonavir, Voriconazole, and
* Clarithromycin)
* Patients who take moderate-to-severe CYP3A inducers (such as Phenytoin, Carbamazapine, and Rifabutin)
Interventions
DRUG
Suzetrigine
DRUG
Placebo
Conditions
Bariatric SurgeryCardiac Surgery With SternotomyPost-operative Pain
Locations
Mount Sinai Morningside
New York, New York 10025
United States