Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 3:11 PM
Study NCT ID:
NCT04279132
Status:
UNKNOWN
Last Update Posted:
2020-02-20
First Post:
2020-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFECT OF ANESTHESİA TECHNIQUES ON POSTOPERATİVE COGNİTİVE DYSFUNCTION FOR MMSE AND NSE LEVEL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'BLOOD SAMPLES'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-07-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MINI MENTAL STATE EXAMINATION TEST', 'timeFrame': '1 MONTH', 'description': 'BELOW 27 SCORE IS ASSOSIATED WITH POSTOPERATIVE COGNITIVE DYSFUNCTION'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Cognitive Dysfunction', 'NEURON SPECIFIC ENOLASE', 'MINI MENTAL STATE EXAMINATION TEST']}, 'referencesModule': {'references': [{'pmid': '25838586', 'type': 'RESULT', 'citation': 'Goswami U, Babbar S, Tiwari S. Comparative evaluation of the effects of propofol and sevoflurane on cognitive function and memory in patients undergoing laparoscopic cholecystectomy: A randomised prospective study. Indian J Anaesth. 2015 Mar;59(3):150-5. doi: 10.4103/0019-5049.153036.'}, {'pmid': '31306716', 'type': 'RESULT', 'citation': 'Luescher T, Mueller J, Isenschmid C, Kalt J, Rasiah R, Tondorf T, Gamp M, Becker C, Sutter R, Tisljar K, Schuetz P, Marsch S, Hunziker S. Neuron-specific enolase (NSE) improves clinical risk scores for prediction of neurological outcome and death in cardiac arrest patients: Results from a prospective trial. Resuscitation. 2019 Sep;142:50-60. doi: 10.1016/j.resuscitation.2019.07.003. Epub 2019 Jul 12.'}, {'type': 'RESULT', 'citation': 'Baysalman HB, Oğuz G, Açıkgöz G, Aksakal FN, Ünver SJJotTA, Dergisi ICS-JTAvR. Total İntravenöz ve Desfluran Anestezilerinin Erken Derlenme ve Kognitif Fonksiyonlara Etkileri. 2011;39(1).'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effects of total intravenous anesthesia and inhalation anesthesia methods on postoperative cognitive dysfunction according to Mini Mental State Examination scores and Neuron Specific Enolase levels in lumbar disc herniectomy operations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lumbal disc herniectomy operation is planned for ASA I, II and III risk group between the ages of 18-65.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n-Lumbal disc herniectomy operation 18-65 age\n\nExclusion Criteria:\n\n* Patients before and after the coronary artery bypass graft surgery\n* patients in the last trimester of pregnancy\n* patients with severe heart failure\n* liver failure\n* kidney failure\n* malignant hyperthermia\n* lactating patients\n* patients with vision or hearing problems\n* patients having difficulty in understanding and speaking Turkish\n* Parkinson's and Alzheimer's disease\n* alcohol and drug addicts\n* morbidly obese patients\n* intraoperative hypotension, hypertension and hypoxemia"}, 'identificationModule': {'nctId': 'NCT04279132', 'briefTitle': 'EFFECT OF ANESTHESİA TECHNIQUES ON POSTOPERATİVE COGNİTİVE DYSFUNCTION FOR MMSE AND NSE LEVEL', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan University'}, 'officialTitle': 'THE EFFECT OF TOTAL INTRAVENOUS ANESTHESIA AND INHALATION ANESTHESIA TECHNIQUES FOR MINI MENTAL STATE EXAMINATION TEST AND NEURON SPECIFIC ENOLASE LEVEL IN LUMBAR DISK HERNIECTOMY OPERATIONS', 'orgStudyIdInfo': {'id': '19/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TOTAL INTRAVENOUS ANESTHESIA', 'interventionNames': ['Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION']}, {'label': 'INHALATION ANESTHESIA', 'interventionNames': ['Behavioral: POSTOPERATIVE COGNITIVE DYSFUNCTION']}], 'interventions': [{'name': 'POSTOPERATIVE COGNITIVE DYSFUNCTION', 'type': 'BEHAVIORAL', 'description': 'NEURON SPECIFIC ENOLASE LEVELS IN LUMBAR DISC HERNIECTOMY WITH GENERAL ANESTHESIA MODALITIES', 'armGroupLabels': ['INHALATION ANESTHESIA', 'TOTAL INTRAVENOUS ANESTHESIA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzincan', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'TÜLAY CEREN ÖLMEZTÜRK KARAKURT', 'role': 'CONTACT', 'email': 'ceren_olmezturk_@hotmail.com', 'phone': '05058616006'}], 'facility': 'Erzincan Byu', 'geoPoint': {'lat': 39.73919, 'lon': 39.49015}}], 'centralContacts': [{'name': 'UFUK KUYRUKLUYILDIZ', 'role': 'CONTACT', 'email': 'drufuk2001@gmail.com', 'phone': '05325840554'}], 'overallOfficials': [{'name': 'TÜLAY CEREN ÖLMEZTÜRK KARAKURT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ERZINCAN BYU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzincan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'TULAY CEREN OLMEZTURK KARAKURT', 'investigatorAffiliation': 'Erzincan University'}}}}