Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-07-02 @ 3:15 AM
Study NCT ID:
NCT03123302
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2017-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Our Anesthesia Experience During MRI Scan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}, {'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 977}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient characteristics anesthesia choice and possible complications during MRI anesthesia.', 'timeFrame': '1 week', 'description': 'To investigate the influence of patient characteristics and anesthesia choice on possible complications of sedation anesthesia during MRI scanning'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI scan, sedation, epilepsia'], 'conditions': ['Epileptic Seizure', 'Intracranial Tumor', 'Intracranial Hypertension', 'Intracranial Aneurysm', 'Vertebra; Anomaly']}, 'descriptionModule': {'briefSummary': 'In this study we aim to investigate the relationship between our anesthesia practice and post procedure complications after MRI scanning with sedation. This is a retrospective, single center observational study. All patients undergoing MRI scan during the study period will be included.', 'detailedDescription': 'In this study we aim to investigate the influence of patient characteristics and anesthesia choice on possible complications in patients undergoing MRI under sedation retrospectively.\n\nAfter one of the routine sedation protocol used in our department was chosen and applied according to the physical status of the patient and the physicians decision, the datas of the patients will be recruited to the study from the medical records . Patient characteristics (age, gender, weight, height), ASA (American Society of Anethesiology) classification, associated diseases will be recorded . After the procedure was completed all the complications during the 2 hours waiting period in the recovery room will be recorded from the medical records. All the complşcation and recovery times will be recorded from the medical records. Whether the patient received radiocontrast material or not will also be recorded. The patients will be called by phone, and will be questioned for the complications, any epileptic seizure attack, or increase in the number of seizures, any admission to emergency room or any in patient admission to the hospital will be recorded which developed in the first week after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing MRI scan wth sedation anesthesia and giving written informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:All patients undergoing MRI scan wth sedation anesthesia and giving written informed consent.\n\nExclusion Criteria: patients refusal to be studied.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03123302', 'briefTitle': 'Our Anesthesia Experience During MRI Scan', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Our Anesthesia Experience During MRI Scan', 'orgStudyIdInfo': {'id': 'MEDAH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Epileptic patients who are sedated with a total dose of propofol 2 mg/kg and midazolam 0.1 mg/kg.'}, {'label': 'Group 2', 'description': 'Epileptic patients who are sedated with a total dose of pentothal 4 mg/kg and midazolam 0.1 mg/kg.'}, {'label': 'Group 3', 'description': 'Non-epileptic patients who are sedated with a total dose of propofol 1 mg/kg and ketamine 1 mg/kg.'}, {'label': 'Group 4', 'description': 'Non-epileptic patients who are sedated with a total dose of midazolame 0.1 mg/kg and ketamine 1 mg/kg.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07058', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'AkdenizU', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Ilker O Aycan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akdeniz University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'department of anesthesiology and reanimation', 'investigatorFullName': 'İlker Onguc Aycan', 'investigatorAffiliation': 'Akdeniz University'}}}}