Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT02687334
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2016-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Cerebral Oxygenation During Anesthesia Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-08', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-02-19', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of cerebral oxygen saturation', 'timeFrame': 'Baseline and 30 minutes', 'description': 'the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cerebral Oxygen Saturation']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2) during anesthesia induction.', 'detailedDescription': 'The aim of this study was to investigate the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood and to identify the covariates between rSO2 and PaCO2 and PaO2 during the period of anesthesia induction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients scheduled for elective radical operations for mastocarcinomaat in the First Hospital of China Medical University will be recruited for the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II, and undergoing a radical operation for mastocarcinoma.\n\nExclusion Criteria:\n\n* Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a history of hypertension or diabetes mellitus, or were allergic to anesthesia drugs used in the study.'}, 'identificationModule': {'nctId': 'NCT02687334', 'briefTitle': 'Changes of Cerebral Oxygenation During Anesthesia Induction', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'Changes of Cerebral Oxygenation During Anesthesia Induction', 'orgStudyIdInfo': {'id': '2015110301'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard general anesthesia induction', 'description': 'Patients scheduled for elective surgery at the First Hospital of China Medical University will be recruited for the study beginning in February 2016.We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia', 'interventionNames': ['Drug: 100% Oxygen']}], 'interventions': [{'name': '100% Oxygen', 'type': 'DRUG', 'description': 'We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia with 100% oxygen', 'armGroupLabels': ['Standard general anesthesia induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'the First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Wen-fei Tan, M.D.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the First Hoapital of China Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate proffesor', 'investigatorFullName': 'Wen-fei Tan', 'investigatorAffiliation': 'China Medical University, China'}}}}