Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-06-25 @ 3:47 AM
Study NCT ID:
NCT01804933
Status:
UNKNOWN
Last Update Posted:
2013-03-05
First Post:
2013-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-04', 'studyFirstSubmitDate': '2013-03-04', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'postoperaive pulmonary function', 'timeFrame': '3days postoperatively', 'description': 'FEV1 FVC PEF'}], 'primaryOutcomes': [{'measure': 'degree of muscle trauma', 'timeFrame': '72h postoperatively', 'description': 'serum CK'}], 'secondaryOutcomes': [{'measure': 'postoperative analgesic requirement', 'timeFrame': '7days postoperatively', 'description': 'consumption of morphine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['profound muscle relaxation', 'muscle trauma', 'postoperative analgesic demand', 'postoperative pulmonary function'], 'conditions': ['Profound Muscle Relaxation', 'Muscle Trauma', 'Postoperative Analgesic Demand', 'Postoperative Pulmonary Function']}, 'descriptionModule': {'briefSummary': 'Although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia often had adverse cardiac effects and was related to 2-year mortality in cancer patients.The use of muscle relaxants allowed the depth of anesthesia to be optimized.However, for many anesthesiologists,in fear of residual postoperative neuromuscular blockade,intraoprative administration of muscle relaxants had to be minimized in spite of poor surgical conditions.\n\nThis study, however, is designed to test the hypothesis that profound neuromusclular blockade reduces muscle trauma caused by self-retaining retractor and thus cut down postoperative analgesic requirement.On the other hand,profound muscle relaxation can decrease postoperative diaphragmatic dysfunction and abdominal muscle trauma, which can improve postoperative pulmonary function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1\\~2,scheduled to undergo upper abdominal surgery by midline incision\n\nExclusion Criteria:\n\n* neuromuscular disorder\n* history of malignant hyperthemia\n* allergy to medications used during general anesthesia'}, 'identificationModule': {'nctId': 'NCT01804933', 'briefTitle': 'Influence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'orgStudyIdInfo': {'id': '伦审[2012]326号'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'conventional neuromuscular blockade', 'description': "No rocuronium will be administered intraoperatively unless there is surgeons' complain or patients movement"}, {'type': 'ACTIVE_COMPARATOR', 'label': 'optimal neuromuscular blockade', 'description': 'Rocuronium dose will be infused to maintain depth of NMB at TOF count 1 intraoperatively', 'interventionNames': ['Drug: profound neuromuscular blockade']}, {'type': 'EXPERIMENTAL', 'label': 'profound neuromuscular blockade', 'description': 'Rocuronium dose will be infused to maintain a depth of NMB to PTC 1\\~2 intraoperatively', 'interventionNames': ['Drug: profound neuromuscular blockade']}], 'interventions': [{'name': 'profound neuromuscular blockade', 'type': 'DRUG', 'description': 'Rocuronium dose will be infused to maintain a depth of NMB to PTC 1\\~2 intraoperatively', 'armGroupLabels': ['optimal neuromuscular blockade', 'profound neuromuscular blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Xiao, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ying Xiao, MD,PhD', 'role': 'CONTACT', 'email': 'xying2603@163.com', 'phone': '13570521662'}], 'overallOfficials': [{'name': 'Ying Xiao, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ying Xiao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ying Xiao', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}