[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636349":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":60,"collaborators":10,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":9,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":10,"maxAge":71,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"National Children's Hospital, Vietnam","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"KETADEX",null,"Pediatric patients undergoing the dexmedetomidine-ketamine spontaneous sedation regimen on cardiac catheterization",[13],"Drug: Spontaneous sedation regimen",{"label":15,"type":10,"description":16,"interventionNames":17},"GA","Pediatric patients undergoing the traditional general anesthesia regimen on cardiac catheterization",[18],"Drug: General anesthesia regimen",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DRUG","Spontaneous sedation regimen","Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"General anesthesia regimen","Patients who are mechanically ventilated, undergo general anesthesia regimen",[15],[30],{"name":31,"affiliation":32,"role":33},"Hong Ha Thi Nguyen, PhD.","Vietnam National Children's Hospital","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Hong Ha Thi Nguyen, PhD","CONTACT","+84904111838","honghant@nch.gov.vn",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Nhat Minh Tran, BPharm, MSc","+84936110303","nhatminh@nch.gov.vn",[45],{"facility":32,"status":46,"city":47,"state":10,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Hanoi","10000","Vietnam","VN",{"type":52,"coordinates":53},"Point",[54,55],105.84117,21.0245,{"lat":55,"lon":54},[58,59],{"name":31,"role":37,"phone":38,"phoneExt":10,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},{"type":33,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Nguyen Thi Hong Ha","Head of Pharmacy Department","100636349","efficacy-and-safety-of-a-combined-dexmedetomidine-ketamine-sedation-regimen-for-pediatric-cardiac-catheterization-100636349",false,"NCT07564531","Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization","Evaluation of the Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization at Vietnam National Children's Hospital","Inclusion Criteria:\n\n* Patients under 18 years of age.\n* Patients indicated for diagnostic or interventional cardiac catheterization.\n\nExclusion Criteria:\n\n* Patients with acute respiratory infections, chromosomal abnormalities, metabolic disorders, or other co-existing medical conditions.\n* Arrhythmias, second- or third-degree atrioventricular (AV) block; patients on mechanical ventilation or requiring vasopressors prior to the procedure.\n* Known history of allergy or hypersensitivity to dexmedetomidine, ketamine, propofol, midazolam, or sevoflurane.","ALL","18 Years",{"count":73,"type":74},150,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn if the spontaneous sedation regimen of dexmedetomidine-ketamine (KETADEX) has the comparable efficacy and safety in pediatric cardiac catheterization versus the traditional regimen. The main question it aims to answer is:\n\nIs the combined Dexmedetomidine-Ketamine spontaneous sedation regimen (KETADEX) non-inferior to the traditional general anesthesia regimen in terms of efficacy and safety?\n\nParticipants would received either KETADEX regimen or general anesthesia regimen. Research members then observe the catheterization procedure and answer the questionnaire about their efficacy and safety.",[78,79],"Cardiac Catheterization","Pediatric",[81,82,83,84,85],"dexmedetomidine","ketamine","spontaneous sedation","general anesthesia","cardiac catheterization","2026-04-29",{"date":88,"type":89},"2026-05-04","ACTUAL",{"date":91,"type":89},"2026-02-04",{"date":93,"type":74},"2026-12-30",{"name":5,"class":6},1]