Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-27 @ 5:14 AM
Study NCT ID:
NCT03179293
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2017-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation
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': 'D015742', 'term': 'Propofol'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-26', 'studyFirstSubmitDate': '2017-06-03', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergence Agitation', 'timeFrame': '30 min after emergence', 'description': 'The incidence of EA according to the Watcha scale (defined as a score ≥3 at any time in the 30 min after emergence)'}, {'measure': 'Emergence Agitation', 'timeFrame': '30 min after emergence', 'description': 'The incidence of EA according to the Paediatric Emergence Anaesthesia Delirium (PAED) scale (defined as a score \\>12 at any time in the 30 min after emergence )'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergence Agitation']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized double-blinded study is to determine whether transition to propofol for 3 min at the end of sevoflurane anaesthesia reduces the incidence of EA in children undergoing genito-urinary paediatric surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children Aged 3 - 8 years\n2. ASA (I - II)\n3. Genito-urinary Surgeries: hernia, varicocele, etc.\n\nExclusion Criteria:\n\n1. Patients or parental refusal\n2. Allergy to Propofol or egg products; or a family history of malignant hyperthermia\n3. Operating time more than 60 minutes\n4. Performance of any other procedure under the same anaesthetic\n5. Presence of co-morbidities or congenital anomalies\n6. mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.'}, 'identificationModule': {'nctId': 'NCT03179293', 'briefTitle': 'Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation in Genito-urinary Paediatric Surgeries', 'orgStudyIdInfo': {'id': 'propofol after sevo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR', 'interventionNames': ['Drug: Propofol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Normal saline will be administered IV over the next 3 min prior to the patient leaving the OR', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR', 'armGroupLabels': ['Propofol']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Normal saline will be administered manually over the next 3 min prior to the patient leaving the OR', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Assiut University hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Mostafa Samy Abbas', 'investigatorAffiliation': 'Assiut University'}}}}