Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-04 @ 6:43 PM
Study NCT ID:
NCT03209193
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2017-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D000077335', 'term': 'Desflurane'}], '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': 'D005019', 'term': 'Ethyl Ethers'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2017-07-03', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tissue oxygen saturation measured at thenar eminence by Hutchinson(R) tissue oximeter during off-pump coronary artery bypass surgery', 'timeFrame': 'Before induction of anesthesia to the end of the surgery, an average 8 hours', 'description': 'Tissue oxygen saturation measured at thenar eminence by tissue oximeter during surgery in patients receiving sevoflurane or desflurane'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['off-pump coronary artery bypass', 'sevoflurane', 'desflurane', 'tissue oxygen saturation'], 'conditions': ['Microcirculation', 'Anesthetic Complication Spinal']}, 'referencesModule': {'references': [{'pmid': '32915370', 'type': 'DERIVED', 'citation': 'Cho YJ, Yoo SJ, Nam K, Bae JY, Lee SH, Jeon Y. Effects of anesthetics on microvascular reactivity measured by vascular occlusion tests during off-pump coronary artery bypass surgery: a randomized controlled trial. J Clin Monit Comput. 2021 Oct;35(5):1219-1228. doi: 10.1007/s10877-020-00587-8. Epub 2020 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'Volatile anesthetics, such as sevoflurane and desflurane, are commonly used in patients undergoing cardiac surgeries including off-pump coronary artery bypass. However, the effect of volatile anesthetics on microcirculation in patients undergoing off-pump coronary artery bypass has not been well conducted.', 'detailedDescription': 'This is a prospective randomized clinical trial investigating the effect of sevoflurane vs. desflurane on tissue microcirculation in patients undergoing off-pump coronary artery bypass surgery. Eligible patients are going to be randomized to receive sevoflurane or desflurane, as a maintenance anesthetic, during the surgery. Tissue oxygen saturation and microcirculatory changes, such as an occlusion and recovery slope, during vascular occlusion test will be recorded during the surgery. The primary end point of the study is the difference in tissue oxygen saturation between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for off-pump coronary artery bypass surgery\n\nExclusion Criteria:\n\n* any deformity or vascular abnormalities on upper arms\n* cannot receive sevoflurane or desflurane for any reason (muscular diseases, etc)\n* uncontrolled diabetes\n* peripheral vascular disease\n* severe renal dysfunction (end-stage renal disease)\n* refuse to enroll\n* pregnant'}, 'identificationModule': {'nctId': 'NCT03209193', 'briefTitle': 'Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery', 'orgStudyIdInfo': {'id': 'OPCAB_SEVO vs DES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane', 'description': 'Sevoflurane (2 vol%) use as a maintenance volatile anesthetic drug during the surgery', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Desflurane', 'description': 'Desflurane (6 vol%) use as a maintenance volatile anesthetic drug during the surgery', 'interventionNames': ['Drug: Desflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'Sevoflurane use as main anesthetic drug during the surgery', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Desflurane', 'type': 'DRUG', 'description': 'Desflurane use as main anesthetic drug during the surgery', 'armGroupLabels': ['Desflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Youn Joung Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Youn Joung Cho, MD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}