RecruitingPhase 3NCT07539623

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


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

235 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSuzetrigine

Suzetrigine is a new pain medication that works by blocking a specific sodium channel (NAV 1.8) in the peripheral nerves and preventing pain signals from reaching the spinal cord and brain.

DRUGPlacebo

Matching placebo


Locations(1)

Mount Sinai Morningside

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07539623


Related Trials