[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634433":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":43,"locations":51,"responsibleParty":70,"collaborators":34,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":34,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":34,"overallStatus":54,"whyStopped":34,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Bariatric Suzetrigine","EXPERIMENTAL","Participants undergoing bariatric surgery will receive 100 mg loading dose (2 pills) of Suzetrigine pre-operatively and 50 mg dose (1 pill) every 12 hours after for a total of 5 days.",[13],"Drug: Suzetrigine",{"label":15,"type":16,"description":17,"interventionNames":18},"Bariatric Placebo","PLACEBO_COMPARATOR","Participants undergoing bariatric surgery will receive 2 pills of a placebo pill made to look like Suzetrigine capsule pre-operatively and 1 pill every 12 hours after for a total of 5 days.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Cardiac Suzetrigine","Participants undergoing cardiac surgery with sternotomy will receive 100 mg loading dose (2 pills) of Suzetrigine pre-operatively and 50 mg dose (1 pill) every 12 hours after for a total of 5 days.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Cardiac Placebo","Participants undergoing cardiac surgery with sternotomy will receive 2 pills made to look like Suzetrigine capsule pre-operatively and 1 pill every 12 hours after for a total of 5 days.",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Suzetrigine","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.",[9,21],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Placebo","Matching placebo",[15,25],[40],{"name":41,"affiliation":5,"role":42},"Himani Bhatt, DO","PRINCIPAL_INVESTIGATOR",[44,48],{"name":41,"role":45,"phone":46,"phoneExt":34,"email":47},"CONTACT","212-523-2500","himani.bhatt@mountsinai.org",{"name":49,"role":45,"phone":46,"phoneExt":34,"email":50},"Michael Lazar, MD","michael.lazar@mountsinai.org",[52],{"facility":53,"status":54,"city":55,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Mount Sinai Morningside","RECRUITING","New York","10025","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-74.00597,40.71427,{"lat":63,"lon":62},[66,67,68],{"name":41,"role":45,"phone":46,"phoneExt":34,"email":47},{"name":49,"role":45,"phone":46,"phoneExt":34,"email":50},{"name":69,"role":42,"phone":34,"phoneExt":34,"email":34},"Himani Bhatt",{"type":42,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Himani Bhatt-Verma","Associate Professor","100634433","phase-3-suzetrigine-enhanced-multimodal-opioid-sparing-therapy-in-cardiac-and-bariatric-surgery-100634433",false,"NCT07539623","Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery","SMOOTH-SURG","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults 18-85 years old\n* Scheduled to undergo cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)\n* All genders\n\nExclusion Criteria:\n\nAny individual who meets any of the following criteria will be excluded from participation in this study:\n\n* ASA Class V\n* Urgent or emergent surgery\n* Contraindications to administration of Suzetrigine (e.g. concomitant use of strong CYP3A inhibitors)\n* History of substance use disorder or chronic opioid use\n* Reoperation\n* Patient refusal or inability to consent\n* Patients who take moderate-to-severe CYP3A inhibitors (such as Ritonavir, Voriconazole, and\n* Clarithromycin)\n* Patients who take moderate-to-severe CYP3A inducers (such as Phenytoin, Carbamazapine, and Rifabutin)","ALL","18 Years","85 Years",{"count":84,"type":85},235,"ESTIMATED","INTERVENTIONAL",[88],"PHASE3","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.",[91,92,93],"Bariatric Surgery","Cardiac Surgery With Sternotomy","Post-operative Pain","2026-05-11",{"date":96,"type":97},"2026-05-14","ACTUAL",{"date":99,"type":97},"2026-05-01",{"date":101,"type":85},"2026-12-22",{"name":5,"class":6},1]