Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-03-04 @ 7:09 PM
Study NCT ID:
NCT00515359
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2007-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2007-08-07', 'studyFirstSubmitQcDate': '2007-08-10', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing', 'timeFrame': 'study completion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sedation', 'MRI', 'pediatric', 'propofol', 'brain', 'spine', 'quality of MRI', 'Continuous propofol dosing', 'continuous propofol administration', 'Intermittent propofol dosing', 'intermittent propofol administration', 'Sedative agent', 'propofol continuous infusions', 'Recovery time', 'Complications of sedation', 'bolus dosing'], 'conditions': ['Encephalopathy', 'Developmental Delay and Behavioral Changes', 'Cord Tumor Compression or Instability', 'Cord Tethering or Malformation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://corewellhealth.org/', 'label': 'Spectrum Health'}]}, 'descriptionModule': {'briefSummary': 'RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies', 'detailedDescription': 'A study comparing the dose of propofol used as a continuous infusion versus intermittent bolus dosing looking at recovery time complications, and quality of the MRI studies in Pediatric Sedation Services for patients age 1 month to 18 years receiving an brain or spine MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1 month to 18 years\n* Receiving a brain or spine MRI with propofol sedation\n* Deemed safe to undergo sedation with propofol based on a pre-sedation examination\n* Patient judged not to require any pre-medication with any other medication except nasal decongestants or anticholinergic medications\n\nExclusion Criteria:\n\n* Patient below or above set age limits.\n* Patient requires MRI studies on other body areas.\n* Patient requires pre-medication with a sedative or tranquilizer\n* Patient requires additional medications during sedation to complete the procedure.\n* Propofol is being used as a rescue sedative to complete the procedure.\n* Propofol is being used as a rescue sedative to complete a procedure that was initiated by another sedative.\n* Patients who develop complications that require termination of the imaging procedure will not be included in the dose or recovery time calculations, but the complication will be counted as such in their respective group and study will be reported as non-diagnostic.\n* Insulin dependent diabetes\n* Thyroid disease'}, 'identificationModule': {'nctId': 'NCT00515359', 'briefTitle': 'RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health West'}, 'officialTitle': 'RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies', 'orgStudyIdInfo': {'id': '2007-140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Dosing', 'description': 'continuous dosing', 'interventionNames': ['Procedure: Continuous Propofol Sedation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intermittent Dosing', 'description': 'Intermittent Dosing', 'interventionNames': ['Procedure: Intermittent Propofol Sedation']}], 'interventions': [{'name': 'Intermittent Propofol Sedation', 'type': 'PROCEDURE', 'description': 'Intermittent versus continuous dosage', 'armGroupLabels': ['Intermittent Dosing']}, {'name': 'Continuous Propofol Sedation', 'type': 'PROCEDURE', 'description': 'intermittent vs continuous dosage', 'armGroupLabels': ['Continuous Dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'overallOfficials': [{'name': 'Nabil Hassan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Helen DeVos Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health West', 'class': 'OTHER'}, 'collaborators': [{'name': "Helen DeVos Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}