[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644067":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":32,"locations":33,"responsibleParty":52,"collaborators":32,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":32,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":32,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":32,"overallStatus":36,"whyStopped":32,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group KP: Ketamine + Propofol.","ACTIVE_COMPARATOR","Group that will receive Propofol and ketamine",[13],"Drug: Ketamine + propofol",{"label":15,"type":10,"description":16,"interventionNames":17},"Group DP: Dexmedetomidine + Propofol","Group that will receive Dexmedetomidine and Propofol",[18],"Drug: Dexmedetomidine + propofol",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ketamine + propofol","Ketamine IV bolus 1 mg\u002Fkg (range commonly 0.5-1.5 mg\u002Fkg) administered as an initial bolus to provide analgesia and hemodynamic support; followed by a propofol infusion 100-150 µg\u002Fkg\u002Fmin (titrated to clinical effect).\n\nRescue propofol boluses 0.5 mg\u002Fkg IV may be given for inadequate sedation",[9],[26],"Sedation",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Dexmedetomidine + propofol","Dexmedetomidine loading dose 1 µg\u002Fkg over 10 minutes (range 0.5-1 µg\u002Fkg reported) followed by maintenance infusion per clinical need; co-administration of propofol infusion 100-150 µg\u002Fkg\u002Fmin, titrated to the sedation target.\n\nRescue propofol boluses 0.5 mg\u002Fkg IV may be used for breakthrough movement or inadequate sedation",[15],[26],null,[34],{"facility":35,"status":36,"city":37,"state":32,"zip":32,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Ain shams university hospital","RECRUITING","Cairo","Egypt","EG",{"type":41,"coordinates":42},"Point",[43,44],31.24967,30.06263,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":32,"email":51},"Noha Tarek Hassan","CONTACT","01000667030","Noha.Hassan@med.asu.edu.eg",{"type":53,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100644067","phase-1-a-comparive-study-of-ketamine-propofol-versus-dexmedetomidine-propofol-sedation-in-pediatric-patients-undergoing-cardiac-catheterization-for-device-closure-of-simple-left-to-right-shunts-100644067",false,"NCT07669012","a Comparive Study of Ketamine-Propofol Versus Dexmedetomidine-Propofol Sedation in Pediatric Patients Undergoing Cardiac Catheterization for Device Closure of Simple Left-to-right Shunts","Inclusion Criteria:\n\n* Age 2-12 years, male or female\n* Weight ≥ 10 kg\n* Scheduled for elective transcatheter device closure of a simple left-to-right shunt, including:\n* Secundum atrial septal defect (ASD) suitable for device closure\n* Small muscular ventricular septal defect (VSD) eligible for percutaneous device closure\n* Patent ductus arteriosus (PDA) closure\n* Procedure performed with transthoracic or transesophageal echocardiographic guidance according to the cardiology team's practice\n* ASA physical status II-III\n* Written informed consent obtained from a parent or legal guardian\n\nExclusion Criteria:\n\n* Cyanotic congenital heart disease\n* Complex congenital cardiac lesions\n* Risk of pulmonary hypertensive crisis\n* Requirement for general anesthesia and cuffed endotracheal tube at the discretion of the cardiology or anesthesia team\n* Baseline oxygen requirement \\> 2 L\u002Fmin\n* Use of noninvasive ventilation\n* Known allergy or intolerance to ketamine, dexmedetomidine, or propofol\n* Significant hepatic impairment\n* Significant renal impairment\n* Advanced atrioventricular block\n* Clinically significant bradyarrhythmia\n* Uncontrolled epilepsy\n* Raised intracranial pressure\n* Severe obstructive sleep apnea\n* Craniofacial anomalies associated with anticipated difficult airway management\n* BMI \\> 97th percentile when judged to confer high risk of sedation-related airway obstruction\n* Current beta-blocker use\n* Current clonidine use\n* Acute upper respiratory tract infection within 2 weeks before the procedure\n* Emergency or add-on procedures\n* Anticipated procedure duration \\\u003C 20 minutes\n* Anticipated procedure duration \\> 3 hours","ALL","2 Years","12 Years",{"count":64,"type":65},124,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","This study aims To compare the safety and efficacy of ketamine-propofol versus dexmedetomidine-propofol sedation in pediatric patients undergoing cardiac catheterization for device closure of simple left-to-right shunts",[71],"Sedation and Analgesia","2026-06-20",{"date":74,"type":75},"2026-06-25","ACTUAL",{"date":77,"type":75},"2025-10-22",{"date":79,"type":65},"2027-02-15",{"name":5,"class":6},1]