[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635733":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":42,"locations":51,"responsibleParty":70,"collaborators":30,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":30,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":30,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":53,"whyStopped":30,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Endeavor Health","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Propofol","EXPERIMENTAL","Participants will receive propofol for intraoperative sedation during transcatheter aortic valve replacement (TAVR).",[13],"Drug: Propofol",{"label":15,"type":10,"description":16,"interventionNames":17},"Dexmedetomidine","Participants will receive dexmedetomidine for intraoperative sedation during transcatheter aortic valve replacement (TAVR).",[18],"Drug: Dexmedetomidine",{"label":20,"type":10,"description":21,"interventionNames":22},"Midazolam and Fentanyl","Participants will receive a combination of midazolam and fentanyl for intraoperative sedation during transcatheter aortic valve replacement (TAVR).",[23,24],"Drug: Midazolam","Drug: Fentanyl",[26,31,34,38],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Propofol will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 5-100 mcg\u002Fkg\u002Fmin, titrated to clinical effect according to standard anesthesia practice.",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Dexmedetomidine will be administered intravenously for intraoperative sedation during transcatheter aortic valve replacement (TAVR), with initiation and maintenance infusion dosing of 0.2-1.0 mcg\u002Fkg\u002Fhr, titrated to clinical effect according to standard anesthesia practice.",[15],{"type":27,"name":35,"description":36,"armGroupLabels":37,"otherNames":30},"Midazolam","Midazolam will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.",[20],{"type":27,"name":39,"description":40,"armGroupLabels":41,"otherNames":30},"Fentanyl","Fentanyl will be administered intravenously for intraoperative sedation during TAVR and titrated to achieve adequate sedation and analgesia according to standard anesthesia practice.",[20],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Jessica Brickner","CONTACT","847-570-1197","jessica.brickner@endeavorhealth.org",{"name":49,"role":45,"phone":46,"phoneExt":30,"email":50},"Nia Moragne","nia.moragne@endeavorhealth.org",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Glenview","Illinois","60026","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-87.78784,42.06975,{"lat":63,"lon":62},[66,67],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},{"name":68,"role":69,"phone":30,"phoneExt":30,"email":30},"David Lyubashevsky, MD","PRINCIPAL_INVESTIGATOR",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","David Lyubashevsky","Anesthesiologist","100635733","phase-4-patient-quality-of-recovery-after-tavr-with-different-sedation-regimens-100635733",false,"NCT07556523","Patient Quality of Recovery After TAVR With Different Sedation Regimens","Inclusion Criteria:\n\n* 18-90 years old, inclusive\n* Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)\n* Speaks English or Spanish\n* Consents to participate\n\nExclusion Criteria:\n\n* Preoperative heart rate \\\u003C 50 bpm or arrhythmias (e.g., AFib with RVR)\n* Conduction abnormalities (e.g., 2nd\u002F3rd degree AV block without pacer)\n* Allergy or contraindication to study drugs\n* Pulmonary artery pressure \\> 70mmHg\n* Morbid obesity BMI \\> 50\n* Pregnancy\n* Unable to consent in English or Spanish","ALL","18 Years","90 Years",{"count":84,"type":85},126,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. The main question this study aims to answer is whether different sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in quality of recovery on the first day after the procedure.\n\nResearchers will compare three commonly used sedation medications (propofol, dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to differences in recovery following a TAVR.\n\nParticipants will:\n\n* Be enrolled before their scheduled TAVR procedure\n* Be randomly assigned to receive one of the three sedation medications during their procedure\n* Complete short surveys on postoperative days 1 and 7 about pain levels, how they feel during their recovery, and how satisfied they were with their anesthesia experience",[91,92],"Transcatheter Aortic Valve Replacement (TAVR)","Aortic Valve Stenosis",[94,95,96,97],"Transcatheter aortic valve replacement","TAVR","Sedation strategy","Anesthesia","2026-04-22",{"date":100,"type":101},"2026-04-29","ACTUAL",{"date":103,"type":101},"2026-03-16",{"date":105,"type":85},"2028-06",{"name":72,"class":6},1]