Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-30 @ 7:15 PM
Study NCT ID:
NCT06869304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Steep Trendelenburg Position on Neurocognitive Functions in Robotic Radical Prostatectomy Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MoCA', 'timeFrame': 'preoperatively', 'description': 'Preoperative MoCA test scores'}, {'measure': 'MoCA', 'timeFrame': 'day 1', 'description': 'postoperative MoCA test scores'}], 'secondaryOutcomes': [{'measure': 'NIRS', 'timeFrame': 'intraoperatively', 'description': 'NIRS values (right \\& left)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurocognitive Disorder', 'Robotic Assisted Laparoscopic Radical Prostatectomy', 'Near Infrared Spectroscopy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of the steep Trendelenburg position in robotic prostatectomy cases, where anesthesia depth is monitored using BIS and cerebral perfusion is tracked with NIRS, and to determine the incidence of neurocognitive dysfunction using the MoCA test in the postoperative period.\n\nSteep Trendelenburg position and CO₂ pneumoperitoneum during robotic radical prostatectomy lead to significant changes in intracranial pressure and cerebral oxygenation, which may contribute to postoperative neurocognitive dysfunction (POCD). Monitoring anesthesia depth with Bispectral Index (BIS) and cerebral perfusion with Near-Infrared Spectroscopy (NIRS) may help detect early neurocognitive changes, and MoCA test assessments will reveal a measurable decline in cognitive function postoperatively.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 65 years and older with ASA II-III risk scores, undergoing robotic radical prostatectomy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 years\n* ASA II-III risk score\n* Patients scheduled for robotic radical prostatectomy\n* Patients who voluntarily agree to participate\n\nExclusion Criteria:\n\n* Age \\< 65 years\n* History of neurological or psychiatric disorders\n* Inability to undergo robotic surgery\n* Conversion to open prostatectomy during surgery\n* Patients who do not consent to participate'}, 'identificationModule': {'nctId': 'NCT06869304', 'briefTitle': 'The Effect of Steep Trendelenburg Position on Neurocognitive Functions in Robotic Radical Prostatectomy Cases', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Examining the Effect of Steep Trendelenburg Position on Neurocognitive Functions With MoCA Test in Robotic-assisted Radical Prostatectomy Surgeries.', 'orgStudyIdInfo': {'id': 'TABED2-24-570'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Montreal Cognitive Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Preoperative and postoperative MoCA test scores'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Özlem Balkız Soyal, md', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ankara City Hospital Bilkent', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Betül Güven Aytaç, Assoc.prof.', 'role': 'CONTACT', 'email': 'drbguven@hotmail.com', 'phone': '+905073578351'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof', 'investigatorFullName': 'Betül Güven', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}