Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 4:31 PM
Study NCT ID:
NCT01461551
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2011-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anesthesia and Lymphocytes Apoptosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'litery0301@163.com', 'phone': '13916667704', 'title': 'Dr. Lijie Jia', 'organization': 'Ruijin Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sevoflurane', 'description': 'Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Propofol', 'description': 'Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Combine of Sevoflurane and Propofol', 'description': 'combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lymphocyte Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sevoflurane', 'description': 'Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)'}, {'id': 'OG002', 'title': 'Combine of Sevoflurane and Propofol', 'description': 'combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '0.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day after surgery', 'description': 'Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.', 'unitOfMeasure': 'cells/nanoliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intensive Care Unit Staying Days', 'timeFrame': 'participants will stay in intensive care unit after surgery, an expected average of 2 days', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sevoflurane', 'description': 'Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)'}, {'id': 'FG001', 'title': 'Propofol', 'description': 'Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)'}, {'id': 'FG002', 'title': 'Combine of Sevoflurane and Propofol', 'description': 'combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patient recruitment took place from October 9, 2011 to January 12, 2012 in Ruijin Hospital. A total of 149 patients scheduled to undergo elective OPCABG surgery were assessed for eligibility, with 105 patients enrolled and allocated randomly.', 'preAssignmentDetails': 'A total of 105 patients enrolled and allocated randomly. Five of these patients were excluded after enrollment (four due to changes in surgical schedules, and one due to severe hemodynamic instability during clamping of the coronary artery and requiring cardiopulmonary bypass).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sevoflurane', 'description': 'Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)'}, {'id': 'BG001', 'title': 'Propofol', 'description': 'Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)'}, {'id': 'BG002', 'title': 'Combine of Sevoflurane and Propofol', 'description': 'combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '8', 'groupId': 'BG000'}, {'value': '62', 'spread': '8', 'groupId': 'BG001'}, {'value': '65', 'spread': '9', 'groupId': 'BG002'}, {'value': '63', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-06', 'studyFirstSubmitDate': '2011-10-19', 'resultsFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-12', 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lymphocyte Count', 'timeFrame': '1 day after surgery', 'description': 'Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.'}], 'secondaryOutcomes': [{'measure': 'Intensive Care Unit Staying Days', 'timeFrame': 'participants will stay in intensive care unit after surgery, an expected average of 2 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['troponin I', 'creatine kinase mb', 'hospital days', 'lymphocyte apoptosis', 'intensive care unit days'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '26205644', 'type': 'DERIVED', 'citation': 'Jia L, Dong R, Zhang F, Wang W, Lu H, Luo Y, Xue Q, Yu B. Propofol Provides More Effective Protection for Circulating Lymphocytes Than Sevoflurane in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1172-9. doi: 10.1053/j.jvca.2015.01.008. Epub 2015 Feb 19.'}], 'seeAlsoLinks': [{'url': 'http://www.shsmu.edu.cn/', 'label': 'Related Info'}, {'url': 'http://www.sjtu.edu.cn/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating lymphocytes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male adults\n* aged 18-80 yr\n* undergoing elective OPCAB surgery containing left anterior descending artery bypass\n\nExclusion Criteria:\n\n* a previous unusual response to any of the experimental anesthetics\n* severe cardiac dysrhythmias or ejection fraction below 30%\n* hemodynamic instability\n* previous surgical coronary artery repair\n* anemia, abnormal leukocytes or coagulopathy\n* severe hypertension\n* severe hepatic (albumin\\<30g,ascites), renal (serum creatinine greater than 2.0 mg/dl) or pulmonary (preoperative pulmonary function tests moderate-severe) dysfunctions\n* concomitant surgical procedures and psychiatric disorders\n* Insulin-dependent diabetics'}, 'identificationModule': {'nctId': 'NCT01461551', 'acronym': 'OPCAB', 'briefTitle': 'Anesthesia and Lymphocytes Apoptosis', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Different Effects of Sevoflurane, Propofol and Combine of Sevoflurane and Propofol Maintained Anesthesia on Peripheral Blood Lymphocytes During Off-pump Coronary Artery Bypass Graft Surgery', 'orgStudyIdInfo': {'id': 'OPCAB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Propofol', 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Combine of sevoflurane and propofol', 'interventionNames': ['Drug: combine of sevoflurane and propofol']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)', 'armGroupLabels': ['Propofol']}, {'name': 'combine of sevoflurane and propofol', 'type': 'DRUG', 'description': 'anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)', 'armGroupLabels': ['Combine of sevoflurane and propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Bu-Wei Yu, Ph.D., M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'Li-Jie Jia', 'investigatorAffiliation': 'Ruijin Hospital'}}}}