[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564619":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Alexandria University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group GD","ACTIVE_COMPARATOR","Anesthesia induction and maintenance with sevoflurane inhalational anesthesia in addition dexmedetomidine diluted in normal saline (NS) to a concentration of 4ug\u002Fml (in a 50 ml syringe) bolus dose will be administered through the IV catheter at 1 ug\u002Fkg over 10 minutes, followed by an infusion rate of dexmedetomidine 0.5ug\u002Fkg\u002Fhr with use of a syringe pump.",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Group GS","PLACEBO_COMPARATOR","Anaesthesia induction and maintenance with sevoflurane inhalational anaesthesia in addition a 50 ml syringe admisinstered at the same initial rate and maintenance rate as would a vloume-matched dexmedetomidine syringe. Syringes will be prepared by an independent party.",[19],"Drug: Saline (NaCl 0,9 %) (placebo)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine","Dexmedetomidine 1ug\u002Fkg bolus administered over 10 minutes followed by a continuous infusion of 0.5ug\u002Fkg\u002Fhr",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Saline (NaCl 0,9 %) (placebo)","Saline (placebo)",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mohamed Okasha, Specialist - MSc","CONTACT","0201006462352","m_adel13@alexmed.edu.eg",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Alexandria University Hospitals - Semouha","RECRUITING","Alexandria","Alexandria Governorate","Egypt","EG",{"type":46,"coordinates":47},"Point",[48,49],29.91582,31.20176,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":35,"phoneExt":26,"email":36},"Mohamed Okasha, Speciaist - MSc",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mohamed Ahmed Adel Okasha","Assistant Lecturer","100564619","phase-4-effect-of-dexmedetomidine-supplementation-to-general-anaesthesia-in-paediatric-transcatheter-closure-of-atrial-septal-defect-100564619",false,"NCT06631534","Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect","Inclusion Criteria:\n\n* Pediatric Patients 3-12 years of age admitted for device closure of ASD secundum\n\nExclusion Criteria:\n\n* ASA IV, V\n* Neurological problems (cerebral palsy, mental retardation, etc.,)\n* Children with chromosomal abnormalities or other multiple congenital anomalies or other complex cardiac anomalies\n* Hepatic or renal insufficiency\n* History of allergy to the drugs used\n* Previous Cardiac Surgery","ALL","3 Years","12 Years",{"count":68,"type":69},30,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters. Additionally he stress reducing effects of dexmedetomidine will be investigated in this population .\n\nThe main questions it aims to answer are:\n\nDoes Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery?\n\nDoes dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients ?\n\nDoes dexmedetomidine exert stress reducing properties in this population?\n\nParticipants will:\n\nEither be administered Dexmedetomidine in a loading\u002Fmaintenance regimen or a placebo, with hemodynamics being monitored at the baseline, intraoperatively and postoperatively, with recovery time and quality of recovery especially emergence delirium being monitored. Stress hormone levels will be sampled at baseline and postoperatively.",[75,23,76,77],"Atrial Septal Defect (ASD)","Delirium - Postoperative","Stress Response",[79,80,23,81,82,83,84,85,86],"Atrial septal Defect","ASD","Echocardiography","Cardiac index","PAED","VTI","Norepinephrine","Corisol","2024-10-10",{"date":89,"type":90},"2024-10-15","ACTUAL",{"date":92,"type":90},"2024-04-03",{"date":94,"type":69},"2024-12",{"name":5,"class":6},1]