Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT02609802
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Different Analgesic Potency of Volatile Anesthetics at Equi-MAC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic potency of volatile anesthetics', 'timeFrame': 'the first 60 min of maintaining a steady state 1 MAC of volatile agents', 'description': 'The analgesic potency was evaluated by surgical pleth index value'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Orthopedic Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to evaluate the difference of analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth index.', 'detailedDescription': 'Volatile anesthetics vary in their relative hypnotic potencies. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetics produced different EEG-derived indices such as bispectral index. However, there was no controlled study that demonstrates the difference of analgesic potency. The aim of this clinical trial is to evaluate the difference of analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing arthroscopic shoulder surgery\n* patients with american society of anesthesiologist physical status I, II\n* patients aged 19-65 years\n* patients obtaining written informed consent\n\nExclusion Criteria:\n\n* patients with a history of any psychiatric or neurological disease\n* patients who had received any medication affecting the central nervous system\n* patients who had received medication affecting the sympathetic or parasympathetic nervous systems\n* patients who have not received interscalene approach brachial plexus block (refusal or failure)\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT02609802', 'briefTitle': 'The Different Analgesic Potency of Volatile Anesthetics at Equi-MAC', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'The Different Analgesic Potency of Sevoflurane and Desflurane at Equi-minimum Alveolar Concentration', 'orgStudyIdInfo': {'id': '2015-09-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane', 'description': 'Anesthesia was maintained with sevoflurane.', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Desflurane', 'description': 'Anesthesia was maintained with desflurane.', 'interventionNames': ['Drug: Desflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['SEVO'], 'description': 'Anesthesia was maintained with sevoflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Desflurane', 'type': 'DRUG', 'otherNames': ['DES'], 'description': 'Anesthesia was maintained with desflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.', 'armGroupLabels': ['Desflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyoungho Ryu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangbuk Samsung Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'Kyoungho Ryu', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}