Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT07302061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia."
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mini Mental State Examination (MMSE)', 'timeFrame': 'Up to 48 hours', 'description': 'Mini Mental State Examination (MMSE) will be recorded as the secondary supportive measure like MOCA.'}], 'primaryOutcomes': [{'measure': 'Early postoperative period (24th and 48th hours) cognitive dysfunction rate', 'timeFrame': 'Up to 48 hours after operation', 'description': 'We will assess postoperative cognitive dysfunction.Cognitive function will be evaluated using the MOCA (Montreal Cognitive Assessment) at 24 and 48 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Pleth Variability Index (PVI, %) to assess intraoperative fluid status', 'timeFrame': 'During Surgery', 'description': 'PVI values will be continuously recorded using non-invasive monitor.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['POCD'], 'conditions': ['Postoperative Cognitive Deficit (POCD)']}, 'descriptionModule': {'briefSummary': 'We frequently encounter cognitive impairments in patients over 65 undergoing Lower extremity surgery, depending on comorbidities and the choice of anesthesia method. The current development of neuraxial anesthesia techniques and close monitoring devices helps us prevent and detect cognitive impairment early in these patients. In this study, we aimed to investigate the effects of different anesthesia techniques (general anesthesia/spinal anesthesia) applied in orthopedic cases on patient fluid status (pleth variablity index) and regional cerebral oxygenation (NIRS), and their relationship with cognitive dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing Lower extremity surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over the age of 65\n* Patients with an American Society of Anesthesiologists (ASA) score of II-III\n* Patients with a Mini Mental State Examination (MMSE) score of ≥24 on the first day before surgery\n\nExclusion Criteria:\n\n* Patients with coagulation disorders\n* Patients with a history of anticoagulant medication use\n* Patients with advanced organ failure\n* Patients with Alzheimer's disease or advanced dementia\n* Patients with allergies to the medications used in the study\n* Mental Retardation\n* Patients with a wound infection at the site of spinal anesthesia\n* Patients with a history of cerebrovascular hemorrhage\n* Patients who did not consent;"}, 'identificationModule': {'nctId': 'NCT07302061', 'acronym': 'AECGSKD002', 'briefTitle': '"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia."', 'organization': {'class': 'OTHER', 'fullName': 'Goztepe Training and Research Hospital'}, 'officialTitle': '"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia."', 'orgStudyIdInfo': {'id': 'AECGSKD002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Anesthesia'}, {'label': 'Spinal anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34744', 'city': 'Istanbul', 'state': 'Kadikoy', 'country': 'Turkey (Türkiye)', 'facility': 'Goztepe training and research hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goztepe Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'research assistant', 'investigatorFullName': 'Aygul Valiyeva', 'investigatorAffiliation': 'Goztepe Training and Research Hospital'}}}}