Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-03 @ 4:49 PM
Study NCT ID:
NCT06631534
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2024-09-25', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic Parameters - Cardiac Output', 'timeFrame': 'Baseline , Perioperatively', 'description': 'Cardiac Output/Cardiac index assessed via VTI derived Stroke volume'}, {'measure': 'Hemodynamic Parameters - Heart Rate', 'timeFrame': 'Baseline , Perioperatively'}, {'measure': 'Hemodynamic Parameters - Mean Arterial Blood Pressure', 'timeFrame': 'Baseline , Perioperatively'}], 'secondaryOutcomes': [{'measure': 'Quality of Recovery', 'timeFrame': 'Perioperatively', 'description': 'Quality of recovery will be assessed in paediatric ICU using the paediatric anaesthesia emergence delirium (PAED) scores every 5 minutes after awakening for 30 minutes'}, {'measure': 'G. Recovery Time', 'timeFrame': 'Perioperatively', 'description': 'The time from application of groin bandage to reach a modified Steward score of ≥ 6'}, {'measure': 'Time to extubation', 'timeFrame': 'Perioperatively', 'description': 'Time from applying of groin bandage and cessation of anaesthetic, to removal of ETT'}, {'measure': 'Stress Hormones', 'timeFrame': 'Baseline , Perioperatively', 'description': 'Norepinephrine level'}, {'measure': 'Stress Hormones', 'timeFrame': 'Baseline , Perioperatively', 'description': 'Cortisol Level'}, {'measure': 'Side Effects', 'timeFrame': 'Perioperatively', 'description': 'Clinically significant Bradycardia: HR less than 60 or decrease 30% Clinically significant Tachycardia: HR increase 30% Clinically significant Hypotension: MAP decrease 30% Clinically significant Hypertension: MAP increase 30% Nausea and vomiting'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial septal Defect', 'ASD', 'Dexmedetomidine', 'Echocardiography', 'Cardiac index', 'PAED', 'VTI', 'Norepinephrine', 'Corisol'], 'conditions': ['Atrial Septal Defect (ASD)', 'Dexmedetomidine', 'Delirium - Postoperative', 'Stress Response']}, 'descriptionModule': {'briefSummary': '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/maintenance 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.', 'detailedDescription': 'Atrial Septal Defect (ASD) is one of the most common congenital anomalies in pediatric and even in adult population, it is associated with a left-to-right shunt resulting in right ventricular (RV) volume overload and increase in pulmonary blood flow eventually culmination in right ventricular heart failure (RVHF) and pulmonary hypertension.\n\nPercutaneous closure of ASD was devised nearly a half century ago, and now constitutes a viable alternative to the standard approach of surgical closure. Anesthesia for pediatric patients undergoing percutaneous closure involves a spectrum from sedation to general anesthesia using a variety of drugs according to institutional protocol.\n\nStress response represents the sum of metabolic nd hormonal perturbations initiated by the hypothalamo-pituitary-adrenal axis in response to the surgical stimulus.\n\nDexmedetomidine is an α2-adrenoreceptor agonist possessing stress ameliorating effects exerted on the central sympathetic outflow. It can be used either alone in sedation or as supplementation to general anesthesia. It possesses a remarkable hemodynamic stability profile and due to its prolonged duration of action, it plays a significant role in reducing emergence delirium.\n\nThis study aims at evaluating utility of dexmedetomidine as a supplementary agent to general anesthesia on hemodynamic stability / cardiac output, reduction of pediatric emergence delirium and stress hormone levels in pediatric patients undergoing transcatheter closure of ASD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT06631534', 'briefTitle': 'Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect', 'orgStudyIdInfo': {'id': '0201930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group GD', 'description': 'Anesthesia induction and maintenance with sevoflurane inhalational anesthesia in addition dexmedetomidine diluted in normal saline (NS) to a concentration of 4ug/ml (in a 50 ml syringe) bolus dose will be administered through the IV catheter at 1 ug/kg over 10 minutes, followed by an infusion rate of dexmedetomidine 0.5ug/kg/hr with use of a syringe pump.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group GS', 'description': '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.', 'interventionNames': ['Drug: Saline (NaCl 0,9 %) (placebo)']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine 1ug/kg bolus administered over 10 minutes followed by a continuous infusion of 0.5ug/kg/hr', 'armGroupLabels': ['Group GD']}, {'name': 'Saline (NaCl 0,9 %) (placebo)', 'type': 'DRUG', 'description': 'Saline (placebo)', 'armGroupLabels': ['Group GS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'state': 'Alexandria Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Okasha, Speciaist - MSc', 'role': 'CONTACT', 'email': 'm_adel13@alexmed.edu.eg', 'phone': '0201006462352'}], 'facility': 'Alexandria University Hospitals - Semouha', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Mohamed Okasha, Specialist - MSc', 'role': 'CONTACT', 'email': 'm_adel13@alexmed.edu.eg', 'phone': '0201006462352'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Mohamed Ahmed Adel Okasha', 'investigatorAffiliation': 'Alexandria University'}}}}