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Recruiting Phase 3 NCT07539623

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

Phase 3 – large-scale trial before approval
Conditions: Bariatric Surgery Cardiac Surgery With Sternotomy Post-operative Pain

Sponsor: Icahn School of Medicine at Mount Sinai

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Overview
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.
Who can participate
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
Suzetrigine
DRUG
Placebo
DRUG
Locations 1
United States (1)
Mount Sinai Morningside
New York , New York
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
22.12.2026
Registry ID
NCT07539623
Source
clinicaltrials.gov
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