[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07539623":3,"trial-entities:NCT07539623":102,"trial-summary:NCT07539623":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":43,"secondary_outcomes":48,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":71,"locations":74,"central_contacts":95,"overall_officials":98,"references":100,"see_also_links":101},"NCT07539623","STUDY-25-00822","Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery","RECRUITING","2026-12-22","2026-05","2026-05-14","2026-05-01","Icahn School of Medicine at Mount Sinai","OTHER",false,"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.",null,[18,19,20],"Bariatric Surgery","Cardiac Surgery With Sternotomy","Post-operative Pain",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},235,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":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.",[35,36],"Bariatric Suzetrigine","Cardiac Suzetrigine",{"type":31,"name":38,"description":39,"armGroupLabels":40},"Placebo","Matching placebo",[41,42],"Bariatric Placebo","Cardiac Placebo",[44],{"measure":45,"description":46,"timeFrame":47},"Opioid Consumption","Total post-operative opioid consumption measured daily in total morphine milligram equivalents.","5 days",[49],{"measure":50,"description":51,"timeFrame":47},"Pain Visual Analog scores","Post-operative pain scores will be measured daily using visual analog scale for pain. Total score from 0-10, higher score indicates more pain.","ALL","18 Years","85 Years",{"inclusion":56,"exclusion":60,"raw_text":70},[57,58,59],"Adults 18-85 years old","Scheduled to undergo cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)","All genders",[61,62,63,64,65,66,67,68,69],"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)","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)",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"status":7,"city":77,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":92},"Mount Sinai Morningside","New York","10025","United States",[81,86,89],{"name":82,"role":83,"phone":84,"email":85},"Himani Bhatt, DO","CONTACT","212-523-2500","himani.bhatt@mountsinai.org",{"name":87,"role":83,"phone":84,"email":88},"Michael Lazar, MD","michael.lazar@mountsinai.org",{"name":90,"role":91},"Himani Bhatt","PRINCIPAL_INVESTIGATOR",{"lat":93,"lon":94},40.71427,-74.00597,[96,97],{"name":82,"role":83,"phone":84,"email":85},{"name":87,"role":83,"phone":84,"email":88},[99],{"name":82,"affiliation":12,"role":91},[],[],{"nct_id":4,"conditions":103,"biomarkers":106},[18,104,105],"Cardiac Surgery","Post-Operative Pain",[],{"nct_id":4,"found":108,"summary":109,"prompt_version":119},true,{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is a randomized study, meaning you would be randomly assigned to receive either Suzetrigine or a placebo. It plans to enroll 235 participants.","completed","Suzetrigine for Pain After Cardiac or Bariatric Surgery","This study is testing a new pain medication called Suzetrigine for people having heart surgery (with a sternotomy, which is a cut through the breastbone) or weight-loss surgery (bariatric surgery). Suzetrigine works by blocking specific pain signals from reaching your brain and spinal cord. Researchers want to see if adding Suzetrigine to standard pain care can reduce the amount of opioid pain medication you need and improve your pain scores after surgery. You may be eligible if you are between 18 and 85 years old and scheduled for one of these surgeries. The study is comparing Suzetrigine to a placebo (an inactive substance). The main goal is to measure how much opioid medication you use over 5 days after surgery. The current recruitment status is unclear.","Your opioid consumption will be measured for 5 days after surgery.",126,"Not specified in the trial record.","Not stated in the trial record.",[32,38],"v2"]