Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-30 @ 8:07 AM
Study NCT ID:
NCT04948957
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2021-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Cerebral Oxygenation and Cognitive Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C036604', 'term': 'esmolol'}, {'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2021-06-12', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effects of controlled hypotension on cerebral oxygen saturation', 'timeFrame': 'until end of the surgical procedure.', 'description': 'influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by measuring regional cerebral oxygen saturation using Near-Infrared Spectroscopy'}], 'secondaryOutcomes': [{'measure': 'effects of controlled hypotension on cognitive function', 'timeFrame': '24 hour before surgery and 24 hour after surgery', 'description': 'influence of nitroglycerin and esmolol-induced hypotension on postoperative cognitive function using mini mental test score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral oxygenation', 'cognitive function', 'esmolol', 'nitroglycerine'], 'conditions': ['Hypotension; Controlled', 'Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'The present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\- required controlled hypotension scheduled for nasal surgeries', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* patients with ASA physical status of I-II\n* aged 18-65 years\n\nExclusion Criteria:\n\n* Age under 18 or above 65\n* ASA \\> II\n* coagulation disorders\n* history of cardiovascular and cerebrovascular disease\n* poor Blood Pressure control\n* anemia, pregnancy, addiction to opioids\n* body mass index (BMI) \\> 35\n* intraoperative systolic BP \\< 65 mmHg\n* surgical duration less than 30 minutes or more than 160 minutes\n* need for an intraoperative sympathomimetic drug and the use of other hypotensive drugs\n* preoperative Mini-Mental State Examination (MMSE) score of 23 or less.'}, 'identificationModule': {'nctId': 'NCT04948957', 'briefTitle': 'Changes in Cerebral Oxygenation and Cognitive Functions', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'Changes in Cerebral Oxygenation and Cognitive Functions During Controlled Hypotension', 'orgStudyIdInfo': {'id': '2013-81-03/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'esmolol (Group E)', 'interventionNames': ['Drug: Esmolol']}, {'label': 'nitroglycerin (Group N)', 'interventionNames': ['Drug: Nitroglycerin']}], 'interventions': [{'name': 'Esmolol', 'type': 'DRUG', 'armGroupLabels': ['esmolol (Group E)']}, {'name': 'Nitroglycerin', 'type': 'DRUG', 'armGroupLabels': ['nitroglycerin (Group N)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67600', 'city': 'Zonguldak', 'state': 'Kozlu', 'country': 'Turkey (Türkiye)', 'facility': 'Zonguldak Bülent Ecevit University Medicine Faculty', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Bengü Gülhan Aydin', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}