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Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery

RecruitingPhase 3Ages 18 Years - 85 YearsAllIcahn School of Medicine at Mount Sinai
NCT07539623 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Suzetrigine
  • Placebo
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Where

1 site
Mount Sinai Morningside
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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