Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 3:04 AM
Study NCT ID:
NCT06396468
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sevoflurane and Intravenous Anesthesia in Hypospadias Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In group Sevoflurane, anesthesia was maintained with sevoflurane (1-1.2 MAC) with oxygen /air 1:1.\n\nIn group propofol , anesthesia was maintained continuous infusion of 100-400 mcg/kg /min of propofol and fentanyl 0.1 ug / kg/ min with oxygen /air 1:1.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-07-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergence delirium', 'timeFrame': '24 hours', 'description': 'The pediatric anesthesia emergence delirium (PAED) scale. Each must be evaluated as not at all, just a little, quite a bit, very much, or extremely, where the first three items to be scored reversely (4 = not at all, 0 = extremely) while the last two items to be scored regularly.'}], 'secondaryOutcomes': [{'measure': 'FLACC', 'timeFrame': 'Postoperatively at 24 hours', 'description': 'The Face, Legs, Activity, Cry, and Consolability scale is a frequently used tool for pain assessment in children, with a total score of 0 to 10'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergence Delirium', 'Intravenous Anesthesia', 'Sevoflurane']}, 'descriptionModule': {'briefSummary': 'Emergence agitation (EA), a phenomenon observed at the time of recovery from general anesthesia (GA).The cause of ED appears to be multifactorial in origin. Use of volatile anesthetics, prolonged duration and type of surgery, pain, and rapid emergence are some factors known to increase its incidence', 'detailedDescription': 'The pathogenesis of postoperative EA is still undefined, but sevoflurane has intrinsic effects that may share in emergence agitation like its different electroencephalogram pattern from halothane, and its degradation to inorganic fluoride ions and compound A which may have a role in the occurrence of EA Sevoflurane now is the inhalational anaesthetic agent of choice for pediatrics, as it is non-pungent, with minimal airway irritation characters, and its cardiac adverse effects are minimal like cardiac depression and dysrhythmias.\n\nTotal intravenous anesthesia (TIVA) using propofol and fentanyl appears to have a smooth recovery profile'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '1 Year', 'genderBased': True, 'genderDescription': 'Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 1 to 8 years\n* American society of anesthesiologists (ASA) physical status I and II, scheduled for hypospadias repair\n\nExclusion Criteria:\n\n* children with a history of active airway disease,\n* sleep apnoea, developmental delay,\n* psychological,\n* neurological disorder,\n* cardiovascular abnormality or requirement of post-operative ventilation,\n* hepatic impairment, and renal insufficiency, with active upper respiratory tract infection'}, 'identificationModule': {'nctId': 'NCT06396468', 'briefTitle': 'Sevoflurane and Intravenous Anesthesia in Hypospadias Repair', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Emergence Delirium in Pediatric Age Group: Comparison Between Sevoflurane and Intravenous Anesthesia in Hypospadias Repair: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RC 28-11-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sevoflurane group', 'description': 'Anesthesia was maintained with sevoflurane (1-1.2 MAC) with oxygen /air 1:1', 'interventionNames': ['Drug: sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Propofol group', 'description': 'Anesthesia was maintained continuous infusion of 100-400 mcg/kg /min of propofol and fentanyl 0.1 ug / kg/ min with oxygen /air 1:1', 'interventionNames': ['Drug: propofol']}], 'interventions': [{'name': 'sevoflurane', 'type': 'DRUG', 'otherNames': ['S group'], 'description': 'sevoflurane (1-1.2 MAC)', 'armGroupLabels': ['sevoflurane group']}, {'name': 'propofol', 'type': 'DRUG', 'otherNames': ['P group'], 'description': '100-400 mcg/kg /min of propofol', 'armGroupLabels': ['Propofol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ramy Saleh, MD', 'role': 'CONTACT', 'email': 'ramymousa455@gmail.com', 'phone': '01024020922', 'phoneExt': '139'}], 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Ramy Saleh, MD', 'role': 'CONTACT', 'email': 'ramymousa455@gmail.com', 'phone': '01024020922', 'phoneExt': '139'}], 'overallOfficials': [{'name': 'Ramy Saleh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt', 'investigatorFullName': 'Ramy Mousa', 'investigatorAffiliation': 'Benha University'}}}}