NCT07539623 Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
| NCT ID | NCT07539623 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Bariatric Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 235 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2026-12-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 235 participants in total. It began in 2026-05-01 with a primary completion date of 2026-12-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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)
Contact & Investigator
Himani Bhatt, DO
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT07539623 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Bariatric Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07539623 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 235 participants.
Is NCT07539623 currently recruiting?
Yes, NCT07539623 is actively recruiting participants. Contact the research team at himani.bhatt@mountsinai.org for enrollment information.
Where is the NCT07539623 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07539623 clinical trial?
NCT07539623 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Himani Bhatt, DO at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 235 participants.