Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-27 @ 1:27 AM
Study NCT ID:
NCT05737459
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sedation and Postoperative Cognitive Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-20', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-Mental Status Test', 'timeFrame': '6 months', 'description': 'Evaluation of the effect of sedation with ketamine and dexmedetomidine on postoperative cognitive functions by Mini-Mental Status Test'}], 'secondaryOutcomes': [{'measure': 'noninvasive mean arterial pressure', 'timeFrame': '6 months', 'description': 'The effect of sedation on perioperative hemodynamics.'}, {'measure': 'The heart rate', 'timeFrame': '6 months', 'description': 'The effect of sedation on perioperative hemodynamics.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Impairment', 'Mini mental status test', 'Hip fractures', 'Ketamine', 'dexmedetomidine'], 'conditions': ['Cognitive Impairment', 'Femoral Fractures']}, 'descriptionModule': {'briefSummary': 'Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. Patients who were given ketamine and dexmedetomidine for sedation were included in the study. The Mini Mental Status Tests of the patients measured on the first and third days of the operation in the preoperative period were determined from the hospital records and recorded.', 'detailedDescription': 'Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. The cognitive functions of these patients, which were evaluated by a Mini-Mental Test in the preoperative period, on the first and third days of surgery, were recorded from routine patient follow-up forms.\n\nSedation scores of the patients evaluated by Intraoperative Alertness/Sedation Scale (OAA/S) Observer Evaluation were recorded. Intraoperative hemodynamic data were recorded. The interventions applied to the patient were performed by anesthesiologists who were not involved in the study according to their preferences as part of the routine. The researchers were not involved in any intervention performed on the patient, only the data were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients sedated with ketamine and dexmedetomidine during spinal anesthesia for hip fracture', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over the age of 65 who underwent surgery under spinal anesthesia due to hip fracture\n* Volunteered to participate in the study\n\nExclusion Criteria:\n\n* Patients who are under the age of 65\n* Patients with known histories of dementia\n* Patients with Alzheimer's disease\n* Patients with central nervous system disease\n* Patients who scored 15 or less according to the Mini Mental Status Test (MMSE)\n* Patients who underwent surgery under general anesthesia\n* Patients who refused to voluntarily participate in the study"}, 'identificationModule': {'nctId': 'NCT05737459', 'briefTitle': 'Sedation and Postoperative Cognitive Functions', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Ataturk Training and Research Hospital'}, 'officialTitle': 'The Effect of Sedation on Postoperative Cognitive Functions in Patients Operated for Hip Fracture Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'IAERH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group K', 'description': 'Those who have been administered ketamine for perioperative sedation'}, {'label': 'Group D', 'description': 'Those who have been administered dexmedetomidine for perioperative sedation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35360', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Katip Çelebi University Atatürk Training and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Derya A Yurtlu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir Katip Celebi University Atatürk Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Ataturk Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Derya Arslan Yurtlu', 'investigatorAffiliation': 'Izmir Ataturk Training and Research Hospital'}}}}