[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642361":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":55,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Remimazolam","EXPERIMENTAL","Participants randomized to this arm will receive intravenous remimazolam for procedural sedation prior to and during the placement of neuraxial anesthesia (spinal or epidural) for their scheduled cesarean delivery. Dosing will be titrated by an unblinded anesthesiologist to achieve a light target sedation level.",[13],"Drug: Remimazolam",{"label":15,"type":16,"description":17,"interventionNames":18},"Dexmedetomidine","ACTIVE_COMPARATOR","Participants randomized to this arm will receive intravenous dexmedetomidine for procedural sedation prior to and during the placement of neuraxial anesthesia (spinal or epidural) for their scheduled cesarean delivery. Dosing will be titrated by an unblinded anesthesiologist to achieve a light target sedation level.",[19],"Drug: Dexmedetomidine",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Administered via multiple weight-based intravenous boluses of 0.03 mg\u002Fkg over 1-2 minutes. Boluses are titrated sequentially until the patient reaches a target Richmond Agitation-Sedation Scale (RASS) score of -1 to -2. Once the target sedation window is initially achieved, the clinical anesthesiologist will ask the patient if they desire additional anxiolysis; additional boluses will be given only upon explicit patient request. Administration terminates immediately upon successful placement of the neuraxial block.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Administered via multiple weight-based intravenous boluses of 0.1 μg\u002Fkg over 1-2 minutes. Boluses are titrated sequentially until the patient reaches a target Richmond Agitation-Sedation Scale (RASS) score of -1 to -2. Once the target sedation window is initially achieved, the clinical anesthesiologist will ask the patient if they desire additional anxiolysis; additional boluses will be given only upon explicit patient request. Administration terminates immediately upon successful placement of the neuraxial block.",[15],[30],{"name":31,"affiliation":32,"role":33},"Benjamin Hyers, MD","Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Alexander Tran","CONTACT","917-767-2701","alexander.tran2@mountsinai.org",[41],{"facility":5,"status":25,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"New York","10029","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.00597,40.71427,{"lat":50,"lon":49},[53,54],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":31,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Benjamin Hyers","Assistant Professor","100642361","phase-4-remimazolam-versus-dexmedetomidine-for-sedation-during-neuraxial-100642361",false,"NCT07651956","Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial","Remimazolam Versus Dexmedetomidine for Procedural Sedation During Neuraxial Anesthesia Placement For Scheduled Cesarean Delivery","Inclusion Criteria:\n\n* Pregnant patient scheduled for cesarean delivery\n* ≥ 18 years old\n* ≥ 37 weeks gestational age\n\nExclusion Criteria:\n\n* Pregnant patients \\\u003C 18 years old\n* Pregnant patients \\\u003C 37 weeks gestational age\n* Has known hypersensitivity to benzodiazepines or dexmedetomidine\n* Has history of chronic benzodiazepine use or misuse","FEMALE","18 Years",{"count":68,"type":69},150,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","Patients presenting for a scheduled cesarean delivery who require a neuraxial anesthetic will be randomized to receive intravenous remimazolam or dexmedetomidine for procedural sedation during the placement of their spinal or epidural anesthesia.",[75,76],"Pregnant People","Anxiety",[78,9,15],"Anxiolysis","NOT_YET_RECRUITING","2026-06-11",{"date":82,"type":83},"2026-06-16","ACTUAL",{"date":85,"type":69},"2026-06",{"date":87,"type":69},"2028-05",{"name":5,"class":6},1]