Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-11 @ 4:16 AM
Study NCT ID:
NCT03349658
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2017-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Oximetry and Anesthetic Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2017-11-17', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in transcranial regional cerebral oxygenation (rSO2)', 'timeFrame': '60 minutes', 'description': 'Assessed every 5 minutes during the procedure'}], 'secondaryOutcomes': [{'measure': 'Post anesthetic complications', 'timeFrame': '1 day', 'description': 'During stay at the post anesthetic care unit. Any new neurological symptoms etc'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total hip arthroplasty', 'cerebral oxygen saturation', 'general anesthesia', 'spinal anesthesia'], 'conditions': ['Disorder of Hip Joint']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the effects of spinal and general anesthesia on transcranial regional cerebral oxygen saturation in geriatric patients undergoing total hip arthroplasty.', 'detailedDescription': 'Geriatric patients who received anesthesia undergoing total hip arthroplasty were randomized by means of a computer-generated randomization order into two groups; general anesthesia group (Group 1) and spinal anesthesia group (Group 2). Before and after induction of the general or spinal anesthesia, patients were monitorized with near infrared spectroscopy for regional cerebral oxygen saturation. Findings were compared statistically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who undergo elective total hip arthroplasty\n* American Society of Anesthesiologists class 1 to 3\n* Ability to consent\n\nExclusion Criteria:\n\n* Pulmonary disease\n* History of allergic reaction to local anaesthetics\n* Peripheral neuropathy\n* Neurologic disease\n* Coagulation disorders'}, 'identificationModule': {'nctId': 'NCT03349658', 'briefTitle': 'Cerebral Oximetry and Anesthetic Technique', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'Evaluation of the Effects of Spinal Versus General Anesthesia on Transcranial Cerebral Oxygen Saturation in Geriatric Patients Undergoing Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'AntalyaTRH 17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'general anesthesia', 'description': 'Patients in this group were randomized to receive general anesthesia.', 'interventionNames': ['Other: general anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'spinal anesthesia', 'description': 'Patients in this group were randomized to receive spinal anesthesia.', 'interventionNames': ['Other: spinal anesthesia']}], 'interventions': [{'name': 'general anesthesia', 'type': 'OTHER', 'description': 'effect of general anesthesia on transcranial regional cerebral oxygen saturation', 'armGroupLabels': ['general anesthesia']}, {'name': 'spinal anesthesia', 'type': 'OTHER', 'description': 'effect of spinal anesthesia on transcranial regional cerebral oxygen saturation', 'armGroupLabels': ['spinal anesthesia']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ozge Dagdelen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Antalya Training and Research Hospital'}, {'name': 'Nilgun Kavrut Ozturk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Training and Research Hospital'}, {'name': 'Ali Sait Kavakli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Training and Research Hospital'}, {'name': 'Ülkü Arslan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}