Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-02 @ 8:17 AM
Study NCT ID:
NCT02601508
Status:
UNKNOWN
Last Update Posted:
2015-11-10
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare of Surgical Condition and Complications With Moderate and Deep NM Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-05-01', 'releaseDate': '2020-04-21'}], 'estimatedResultsFirstSubmitDate': '2020-04-21'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'C101584', 'term': 'cisatracurium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-08', 'studyFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2015-11-08', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical rating SCORE(SRS)', 'timeFrame': 'every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery', 'description': 'excellent (5), good but not optimal (4), moderate (3), poor but acceptable (2) or poor and unacceptable (1)'}], 'secondaryOutcomes': [{'measure': 'Respiratory rate', 'timeFrame': 'every 15 minutes from the arrival on the recovery room, up to 60 minutes', 'description': 'Respiratory rate of patient'}, {'measure': 'peripheral arterial oxygen saturation', 'timeFrame': 'every 15 minutes from the arrival on the recovery room, up to 60 minutes', 'description': 'peripheral arterial oxygen saturation(sPO2)'}, {'measure': 'visual analogue scale (VAS) for pain', 'timeFrame': 'every 15 minutes from the arrival on the recovery room, up to 60 minutes', 'description': 'visual analogue scale (VAS) for pain'}, {'measure': 'occurrence of nausea or vomiting', 'timeFrame': 'every 15 minutes from the arrival on the recovery room, up to 60 minutes', 'description': 'occurrence of nausea or vomiting with Rhodes Index'}, {'measure': 'the level of sedation or alertness', 'timeFrame': 'every 15 minutes from the arrival on the recovery room, up to 60 minutes', 'description': 'the level of sedation or alertness with OAA/S scale'}, {'measure': 'Postoperative Quality Recovery Scale (PQRS)', 'timeFrame': 'at baseline (the day before surgery), at 1 hour after surgery, at 6 hours after surgery, at 24 hours after surgery and at 7 days after surgery', 'description': 'physiologic, nociceptive, emotive, cognitive and activities of daily living'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['deep NM block', "Surgeon's satisfaction", 'bridion'], 'conditions': ['Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': "This study is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.The explorative objective of this study is to evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of postoperative complications.", 'detailedDescription': 'Neuromuscular blocking agents (NMBAs) are frequently using during anesthesia to facilitate tracheal intubation and to improve surgical conditions. In an adequately anesthetized and monitored patient, the presence of one or two responses in the train-of-four (TOF) pattern normally indicates sufficient relaxation for most surgical procedures in general practices. It has been called moderate neuromuscular blockade (mNMB) condition. Nowadays, laparoscopic surgeries have expanded impressively into various areas of surgeries, both in scope and volume. If any hypothetical advantages of deep neuromuscular blockade (dNMB) during laparoscopic surgery turned out to be realized in practice with sufficient supporting evidence, it would become an important anesthetic option for better patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to rocuronuim, cisatracurium or sugammadex\n* Significant liver or kidney dysfunction\n* Any neuromuscular disease\n* Pregnant or breast feeding\n* Indication for rapid sequence induction\n* Inability to give informed consent\n* Patients taking any medication with potential interference with neuromuscular transmission'}, 'identificationModule': {'nctId': 'NCT02601508', 'acronym': 'MISPCNUHH', 'briefTitle': 'Compare of Surgical Condition and Complications With Moderate and Deep NM Block', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'A Randomized, Parallel Design, Single-center Study to Compare of Surgical Condition and Postoperative Complications With Moderate and Deep Neuromuscular Blockade in Laparoscopic Gastrectomy', 'orgStudyIdInfo': {'id': 'CNUHH-2015-135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Modarate Blockade Group', 'description': 'Neuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine \\& glycopyrrolate will be given for the recovery.', 'interventionNames': ['Drug: cis-atracurium']}, {'type': 'EXPERIMENTAL', 'label': 'Deep Blockade Group', 'description': 'Neuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery.', 'interventionNames': ['Drug: Rocuronium']}], 'interventions': [{'name': 'Rocuronium', 'type': 'DRUG', 'otherNames': ['Esmeron®'], 'description': 'Continuous infusion of rocuronium for PTC 1 + Sugammadex', 'armGroupLabels': ['Deep Blockade Group']}, {'name': 'cis-atracurium', 'type': 'DRUG', 'otherNames': ['Nimbex®'], 'description': 'Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine \\& Glycopyrrolate', 'armGroupLabels': ['Modarate Blockade Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519-763', 'city': 'Hwasun', 'country': 'South Korea', 'contacts': [{'name': 'Chanhong Park, BsC', 'role': 'CONTACT', 'email': 'cnuhpch@naver.com', 'phone': '+82-61-379-7598'}, {'name': 'Seongheon Lee, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Inje Kim, BsC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shi Young Chung, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Seongwook Jeong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chonnam University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}], 'centralContacts': [{'name': 'SEONGHEON LEE, MD, PhD', 'role': 'CONTACT', 'email': 'headheadhead@naver.com', 'phone': '+82-10-8612-9548'}, {'name': 'Shiyoung JEONG, MD', 'role': 'CONTACT', 'phone': '+82-10-9440-8415'}], 'overallOfficials': [{'name': 'SEONGWOOK JEONG, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Seongwook Jeong', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-04-21', 'type': 'RELEASE'}, {'date': '2020-05-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Seongwook Jeong, associate professor, Chonnam National University Hospital'}}}}