Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT04830293
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2021-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-01', 'studyFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in cognitive functions', 'timeFrame': '3 months after surgery', 'description': 'determine cognitive dysfunction using mini mental state examination'}], 'secondaryOutcomes': [{'measure': 'Changes in Cerebral Perfusion', 'timeFrame': 'during surgery', 'description': 'Changes in main carotid artery blood flow and cerebral oxygenation by using carotid doppler'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Head position', 'Cerebral Oxygenation', 'Postoperative Cognitive Dysfunction'], 'conditions': ['Thyroid', 'Carotid Doppler', 'Cerebral Perfusion']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to observe the effect of head-neck position of patients scheduled for thyroidectomy, on carotid artery blood flow, regional cerebral oxygen saturation measured using near-infrared spectroscopy technology, and postoperative cognitive dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients between the ages of 18-50 who will undergo total thyroidectomy under general anesthesia due to elective thyroid cancer, Hashimoto's thyroiditis or thyrotoxicosis, in the American Society of Anesthesiologists (ASA) I-II risk group, who are euthyroid in the preoperative period", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergo a total thyroidectomy operation\n* ASA I-II\n* euthyroid patients in the preoperative period\n\nExclusion Criteria:\n\n* Hemoglobin\\< 8 g / dl\n* Hypertension\n* Hyperlipidemia\n* Pregnancy\n* Patients diagnosed with diabetes mellitus\n* Cerebrovascular insufficiency\n* Known carotid artery lesion\n* Metabolic diseases\n* Any intracranial pathology present\n* Surgeries exceeding 180 minutes'}, 'identificationModule': {'nctId': 'NCT04830293', 'briefTitle': 'Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'The Effect of Head Position During Thyroidectomy on Cerebral Oxygenation and Postoperative Cognitive Functions', 'orgStudyIdInfo': {'id': '2119-40-14/02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Carotis Doppler Ultrasound', 'type': 'PROCEDURE', 'description': 'Neck was rotated about 30-45 ° to the opposite side of the image. The common carotid artery and internal jugular vein were viewed transversely on the B Mode USG image. Then, the probe was rotated approximately 90 ° and the carotid artery was visualized in the longitudinal plane. The probe and guide line were adjusted so that the Doppler angle was 60 °. The image was created with the guiding line parallel to the blood flow. After imaging of the carotid artery bifurcation, measurements were made 1 cm distal to this level.'}]}, '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': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor doctor', 'investigatorFullName': 'Bengü Gülhan Aydin', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}