Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-24 @ 7:38 PM
Study NCT ID:
NCT01757561
Status:
COMPLETED
Last Update Posted:
2015-09-18
First Post:
2012-12-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gjunying@aliyun.com', 'phone': '8602087755766(8273)', 'title': 'Juan-ying Guo', 'organization': 'FirstSunYetSen'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'the day of surgery and 1 week after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Propofol-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\npropofol: use total intravenous anesthesia with propofol', 'otherNumAtRisk': 38, 'otherNumAffected': 1, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Propofol-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\npropofol: use total intravenous anesthesia with propofol', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sevoflurane-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sevoflurane-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane', 'otherNumAtRisk': 34, 'otherNumAffected': 2, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\npropofol: use total intravenous anesthesia with propofol'}, {'id': 'OG001', 'title': 'Propofol-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\npropofol: use total intravenous anesthesia with propofol'}, {'id': 'OG002', 'title': 'Sevoflurane-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane'}, {'id': 'OG003', 'title': 'Sevoflurane-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline ,every hour in the operation period,after extubation', 'description': 'SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2\\<50%.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\npropofol: use total intravenous anesthesia with propofol'}, {'id': 'OG001', 'title': 'Propofol-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\npropofol: use total intravenous anesthesia with propofol'}, {'id': 'OG002', 'title': 'Sevoflurane-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane'}, {'id': 'OG003', 'title': 'Sevoflurane-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane'}], 'classes': [{'title': '1--3days after operation', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': '5-7 days after operation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-3days、5-7days after operation', 'description': 'The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group ≤ 17, primary and secondary school group ≤ 20, junior high school and above group ≤ 24，or the MoCA score decreased 20% with the baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia', 'timeFrame': 'before anesthesia, after extubation ,1day after operation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia', 'timeFrame': 'before anesthesia,after extubation,1 day after operation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs', 'timeFrame': 'baseline , evey hour in the operation,afte extubation', 'description': 'heart rate, artery blood pressure,pulse oxygen saturation,temperature', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Gas Analysis', 'timeFrame': 'baseline,every hour in the operation,after extubation', 'description': 'including artery blood and blood from jugular vein bulb', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Propofol-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\npropofol: use total intravenous anesthesia with propofol'}, {'id': 'FG001', 'title': 'Propofol-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\npropofol: use total intravenous anesthesia with propofol'}, {'id': 'FG002', 'title': 'Sevoflurane-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane'}, {'id': 'FG003', 'title': 'Sevoflurane-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Propofol-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\npropofol: use total intravenous anesthesia with propofol'}, {'id': 'BG001', 'title': 'Propofol-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\npropofol: use total intravenous anesthesia with propofol'}, {'id': 'BG002', 'title': 'Sevoflurane-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane'}, {'id': 'BG003', 'title': 'Sevoflurane-Normal', 'description': 'patients with preoperative SjvO2≥55%\n\nsevoflurane: use inhalation anesthesia with sevoflurane'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '69', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '64.2', 'spread': '8.3', 'groupId': 'BG002'}, {'value': '67.2', 'spread': '8.5', 'groupId': 'BG003'}, {'value': '65.7', 'spread': '8.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ASA', 'classes': [{'title': 'ASAⅡ', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}]}, {'title': 'ASA Ⅲ', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'ASA I No organic, physiologic, biochemical or psychiatric disturbance ASA II A patient with mild systemic disease that results in no functional limitation. Examples: well-controlled hypertension, uncomplicated diabetes mellitus.\n\nASA III A patient with severe systemic disease that results in functional impairment ASA IV Severe systemic disease that is a constant threat to life. ASA V Moribund condition in a patient who is not expected to survive with or without the operation.\n\nASA VI Declared brain death patient whose organs are being harvested for transplantation.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2012-12-18', 'resultsFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2012-12-28', 'lastUpdatePostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-18', 'studyFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vital Signs', 'timeFrame': 'baseline , evey hour in the operation,afte extubation', 'description': 'heart rate, artery blood pressure,pulse oxygen saturation,temperature'}, {'measure': 'Blood Gas Analysis', 'timeFrame': 'baseline,every hour in the operation,after extubation', 'description': 'including artery blood and blood from jugular vein bulb'}], 'primaryOutcomes': [{'measure': 'the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia', 'timeFrame': 'baseline ,every hour in the operation period,after extubation', 'description': 'SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2\\<50%.'}], 'secondaryOutcomes': [{'measure': 'the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia', 'timeFrame': '1-3days、5-7days after operation', 'description': 'The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group ≤ 17, primary and secondary school group ≤ 20, junior high school and above group ≤ 24，or the MoCA score decreased 20% with the baseline.'}, {'measure': 'the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia', 'timeFrame': 'before anesthesia, after extubation ,1day after operation'}, {'measure': 'the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia', 'timeFrame': 'before anesthesia,after extubation,1 day after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['jugular bulb oxygen saturation', 'postoperative cognitive dysfunction', 'propofol', 'sevoflurane'], 'conditions': ['Cerebral Hypoxia', 'Postoperative Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to investigate whether propofol and sevoflurane have difference effect on cerebral oxygenation .', 'detailedDescription': 'the purpose of this study:(1) to investigate the incidence of preoperative cerebral oxygenation abnormity (SjvO2 \\<55%) and its relationship with intraoperative cerebral desaturation and POCD. (2) To investigate the change of intraoperative cerebral oxygen supply and demand balance and the incidence of cerebral desaturation in patients with abnormal preoperative cerebral oxygenation during sevoflurane anesthesia. (3)To investigate the incidence of early POCD in patients with abnormal preoperative cerebral oxygenation during sevoflurane and propofol anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective major surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled to take major surgery under general anesthesia over 18 years old classified as ASA class three or less\n\nExclusion Criteria:\n\n* have a diagnosis of cerebrovascular disorder'}, 'identificationModule': {'nctId': 'NCT01757561', 'briefTitle': 'The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'The Difference in Cerebral Oxygenation Between Propofol and Sevoflurane', 'orgStudyIdInfo': {'id': '伦审[2012]324号'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Propofol-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%,using the TIVA technology with propofol,', 'interventionNames': ['Procedure: propofol']}, {'label': 'Propofol-Normal', 'description': 'patients with preoperative SjvO2≥55%,using the TIVA technology with propofol,', 'interventionNames': ['Procedure: propofol']}, {'label': 'Sevoflurane-Abnormal', 'description': 'patients with preoperative SjvO2\\<55%,using the VIMA technology with sevoflurane,', 'interventionNames': ['Procedure: sevoflurane']}, {'label': 'Sevoflurane-Normal', 'description': 'patients with preoperative SjvO2≥55%,using the VIMA technology with sevoflurane,', 'interventionNames': ['Procedure: sevoflurane']}], 'interventions': [{'name': 'propofol', 'type': 'PROCEDURE', 'description': 'use total intravenous anesthesia with propofol', 'armGroupLabels': ['Propofol-Abnormal', 'Propofol-Normal']}, {'name': 'sevoflurane', 'type': 'PROCEDURE', 'description': 'use inhalation anesthesia with sevoflurane', 'armGroupLabels': ['Sevoflurane-Abnormal', 'Sevoflurane-Normal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'the First Affiliated Hospital of Sun YetSen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Guo J Ying, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'the First Affiliated Hospital of SunYetSen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Jun-ying Guo', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}