Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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
Qualifiers
Adults 18-85 years old
Scheduled to undergo cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)
All genders
Disqualifiers
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
Trial design
Treatments tested in this trial
- Suzetrigine
- Placebo
Treatment groups
235 Participants
are divided into 4 treatment groupsLocations
1Mount Sinai Morningside10025, New YorkNew York, United States
Sponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
Source ClinicalTrials.gov