[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656931":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":35,"interventions":48,"overallOfficials":57,"centralContacts":61,"locations":66,"responsibleParty":81,"collaborators":26,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":26,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":26,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":106,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of intra-procedural hypotension","Incidence of intra-procedural hypotension defined as MAP \\\u003C65 mmHg or \\>20% decrease from baseline.","during procedure",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Number of Procedural Success","Successful completion of TEE without conversion to general anesthesia or change in sedative strategy.","Immediately after procedure",{"measure":19,"description":20,"timeFrame":21},"Time to recovery","Time from completion of TEE to recovery adequate for discharge from the procedural recovery area.","Time in recovery area, average of 2-4 hours",{"measure":23,"description":24,"timeFrame":25},"Incidence of treatment-related adverse events","Incidence of treatment-related adverse events, including hypotension, bradycardia, hypoxia, nausea\u002Fvomiting, and need for vasoactive medications or rescue sedation.","up to 24 hours",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"SINGLE",[34],"PARTICIPANT",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Propofol group","ACTIVE_COMPARATOR","Control group receiving standard therapy. 50-100mg\u002Fkg\u002Fmin titrated at the discretion of the anesthesiology team",[41],"Drug: Propofol",{"label":43,"type":44,"description":45,"interventionNames":46},"Remimazolam group","EXPERIMENTAL","Study group receiving study drug 0.1-0.2mg\u002Fkg\u002Fmin titrated to effect",[47],"Drug: Remimazolam",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":26},"DRUG","Remimazolam","An initial IV dose followed by supplemental IV doses administered by the anesthesia team, titrated to sedative effect consistent with FDA-approved dosing, for the duration of the TEE procedure.",[43],{"type":50,"name":55,"description":52,"armGroupLabels":56,"otherNames":26},"Propofol",[37],[58],{"name":59,"affiliation":5,"role":60},"Himani V. Bhatt","PRINCIPAL_INVESTIGATOR",[62],{"name":59,"role":63,"phone":64,"phoneExt":26,"email":65},"CONTACT","212-523-6915","himani.bhatt@mountsinai.org",[67],{"facility":68,"status":26,"city":69,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Mount Sinai Morningside","New York","10025","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-74.00597,40.71427,{"lat":77,"lon":76},[80],{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},{"type":60,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Himani Bhatt-Verma","Associate Professor","100656931","phase-4-the-use-of-remimazolam-for-tee-100656931",false,"NCT07829458","The Use of Remimazolam for TEE","Remimazolam for Procedural Sedation in Cardiac Patients Undergoing Transesophageal Echocardiogram Procedures","Inclusion Criteria:\n\n* 18 years of age and older\n* all cardiac patients undergoing elective TEE examination\n\nExclusion Criteria:\n\n* Patients with hypersensitivity to dextrans\n* Emergent procedures\n* Patient with allergy to any of the anesthetic agents\n* Patient refusal","ALL","18 Years",{"count":94,"type":95},210,"ESTIMATED","INTERVENTIONAL",[98],"PHASE4","This is a prospective randomized study. The purpose of this study is to compare the use of remimazolam vs propofol (standard practice) for transesophageal echocardiogram (TEE). Remimazolam was approved by the Pharmacy and Therapeutics committee as a formulary addition to be utilized by anesthesiology for procedural sedation in October 2021. Cardiac patients undergoing TEE procedures at Mount Sinai Morningside Medical Center will be evaluated - 100 patients with be randomized to either receive remimazolam or standard anesthesia. Research participation will include the following activities: prospective access to the Medical Record through Epic only (no other database). Consent to collect patient data for this study will be obtained from subjects by the anesthesiologist at the same time as obtaining consent for the medical procedure.",[101,102],"Cardiac Disease","Anesthesia",[104,105],"Transesophageal echocardiogram","sedation anesthesia","NOT_YET_RECRUITING","2026-09-14",{"date":109,"type":110},"2026-09-21","ACTUAL",{"date":112,"type":95},"2026-09",{"date":114,"type":95},"2027-09",{"name":5,"class":6},1]