Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT03576118
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2018-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kjyeop@ajou.ac.kr', 'phone': '+82312195574', 'title': 'Dr. Jong Yeop Kim', 'organization': 'Ajou University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'baseline, end of pneumoperitoneum, 24 hr after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Deep Neuromuscular Block', 'description': 'Deep neuromuscular relaxation and low pressure pneumoperitoneum\n\nDeep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Moderate Neuromuscular Block', 'description': 'Moderate neuromuscular relaxation and standard pressure pneumoperitoneum\n\nModerate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Cytokine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Block', 'description': 'Deep neuromuscular relaxation and low pressure pneumoperitoneum\n\nDeep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Block', 'description': 'Moderate neuromuscular relaxation and standard pressure pneumoperitoneum\n\nModerate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum'}], 'classes': [{'title': 'IL-6, baseline', 'categories': [{'measurements': [{'value': '35.9', 'spread': '16.85', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '8.67', 'groupId': 'OG001'}]}]}, {'title': 'IL-6, end of pneumoperitoneum', 'categories': [{'measurements': [{'value': '31.4', 'spread': '14.85', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '9.52', 'groupId': 'OG001'}]}]}, {'title': 'IL-6, 24 hr after surgery', 'categories': [{'measurements': [{'value': '41.53', 'spread': '16.29', 'groupId': 'OG000'}, {'value': '32.9', 'spread': '10.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, end of pneumoperitoneum, 24 hr after surgery', 'description': 'change of IL-6 (pg/ml)', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Deep Neuromuscular Block', 'description': 'Deep neuromuscular relaxation and low pressure pneumoperitoneum\n\nDeep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum'}, {'id': 'FG001', 'title': 'Moderate Neuromuscular Block', 'description': 'Moderate neuromuscular relaxation and standard pressure pneumoperitoneum\n\nModerate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Deep Neuromuscular Block', 'description': 'Deep neuromuscular relaxation and low pressure pneumoperitoneum\n\nDeep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum'}, {'id': 'BG001', 'title': 'Moderate Neuromuscular Block', 'description': 'Moderate neuromuscular relaxation and standard pressure pneumoperitoneum\n\nModerate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '7', 'groupId': 'BG000'}, {'value': '44', 'spread': '9', 'groupId': 'BG001'}, {'value': '44', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-01', 'size': 222934, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-28T08:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-31', 'studyFirstSubmitDate': '2018-06-14', 'resultsFirstSubmitDate': '2020-03-28', 'studyFirstSubmitQcDate': '2018-06-22', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-31', 'studyFirstPostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Cytokine', 'timeFrame': 'baseline, end of pneumoperitoneum, 24 hr after surgery', 'description': 'change of IL-6 (pg/ml)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biotrauma', 'laparoscopic surgery', 'neuromuscular block', 'sugammadex'], 'conditions': ['Pneumoperitoneum']}, 'descriptionModule': {'briefSummary': 'The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.', 'detailedDescription': 'Mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. These mechanical forces also induce an increase in the concentrations of inflammatory cytokines.\n\nThe benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. The investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. The investigators hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8 mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I or II, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position\n\nExclusion Criteria:\n\n* cerebrovascular disease\n* uncontrolled hypertension, asthma, COPD\n* neuromuscular disorder\n* patients who have had abdominal surgery\n* morbid obesity (body mass index \\> 35 kg/m2)'}, 'identificationModule': {'nctId': 'NCT03576118', 'briefTitle': 'Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy', 'orgStudyIdInfo': {'id': 'AJIRB-MED-OBS-18-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deep neuromuscular block', 'description': 'Deep neuromuscular relaxation and low pressure pneumoperitoneum', 'interventionNames': ['Drug: Deep neuromuscular block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate neuromuscular block', 'description': 'Moderate neuromuscular relaxation and standard pressure pneumoperitoneum', 'interventionNames': ['Drug: Moderate neuromuscular block']}], 'interventions': [{'name': 'Deep neuromuscular block', 'type': 'DRUG', 'otherNames': ['Deep neuromuscular block with rocumeron'], 'description': 'Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum', 'armGroupLabels': ['Deep neuromuscular block']}, {'name': 'Moderate neuromuscular block', 'type': 'DRUG', 'otherNames': ['Moderate neuromuscular block with rocumeron'], 'description': 'Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum', 'armGroupLabels': ['Moderate neuromuscular block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Jong Yeop Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University Hospital, Suwon, Gyeongki-do, Korea,'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jong Yeop Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}