Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-03-07 @ 11:01 PM
Study NCT ID:
NCT03019835
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2016-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can we Antagonize Mivacurium With Neostigmine ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009388', 'term': 'Neostigmine'}], 'ancestors': [{'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in TOF ( Train Of Four) measure', 'timeFrame': 'for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mivacurium', 'neostigmine', 'antagonism'], 'conditions': ['Mivacurium', 'Neostigmine', 'Residual Paralysis']}, 'referencesModule': {'availIpds': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/7880668', 'type': 'Study Protocol'}], 'references': [{'pmid': '7880668', 'type': 'RESULT', 'citation': "Baurain MJ, Dernovoi BS, d'Hollander AA, Hennart DA. Comparison of neostigmine-induced recovery with spontaneous recovery from mivacurium-induced neuromuscular block. Br J Anaesth. 1994 Dec;73(6):791-4. doi: 10.1093/bja/73.6.791."}, {'pmid': '16183681', 'type': 'RESULT', 'citation': "Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM. Postoperative residual neuromuscular block: a survey of management. Br J Anaesth. 2005 Nov;95(5):622-6. doi: 10.1093/bja/aei240. Epub 2005 Sep 23."}, {'pmid': '10719950', 'type': 'RESULT', 'citation': 'Szenohradszky J, Fogarty D, Kirkegaard-Nielsen H, Brown R, Sharma ML, Fisher DM. Effect of edrophonium and neostigmine on the pharmacokinetics and neuromuscular effects of mivacurium. Anesthesiology. 2000 Mar;92(3):708-14. doi: 10.1097/00000542-200003000-00015.'}]}, 'descriptionModule': {'briefSummary': 'The antagonism of neuromuscular blocking agents (NMBA) (or curares), as well as the antagonism of other drugs used in anesthesia, is a major challenge for the speciality.\n\nResidual paralysis is indeed a risk factor for post-operative morbidity and mortality and antagonization of curares at the end of the procedure is associated with a reduction in mortality .\n\nIts use should be as large as possible and its contraindications are extremely rare.\n\nThe antagonism of the NMBA reduces the duration of the neuromuscular block and the complications that are associated .\n\nIn this study, the investigators use mivacurium (or Mivacron) as non-depolarizing curare and neostigmine as an antagonist.\n\nNeostigmine reduces the duration of the neuromuscular block induced by mivacurium, By reducing the breakdown of acetylcholine, neostigmine induces an increase in acetylcholine in the synaptic cleft which competes for the same binding site as nondepolarizing neuromuscular blocking agents, and reverses the neuromuscular blockade.\n\nBut the use of neostigmine in current practice is not very widespread in this clinical situation.\n\nThe reduction in the duration of the block is significant in comparison with a spontaneous recovery .\n\nMoreover, spontaneous recovery is not always complete and sometimes very long.\n\nNevertheless, its action is effective and this study could support this use but also specify the duration and the quality of the return to normal of the neuromuscular transmission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients American Society of Anesthesiologists (ASA) 1 to 3\n* Absence of neuromuscular disease, renal and hepatic insufficiency\n* Absence of medication that could interfere with the mediators of the neuromuscular junction\n\nExclusion Criteria:\n\n* Bronchial asthma\n* Parkinson disease\n* BMI\\> 35\n* Known hypersensitivity to neostigmine or to any of the excipients of Neostigmine'}, 'identificationModule': {'nctId': 'NCT03019835', 'briefTitle': 'Can we Antagonize Mivacurium With Neostigmine ?', 'organization': {'class': 'OTHER', 'fullName': 'Université Libre de Bruxelles'}, 'officialTitle': 'Can we Antagonize Mivacurium With Neostigmine', 'orgStudyIdInfo': {'id': 'B406201629996'}, 'secondaryIdInfos': [{'id': 'U1111-1190-7993', 'type': 'OTHER', 'domain': 'WHO-UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP 1', 'description': "A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 1 response of 4 in TOF mode (Train Of Four)", 'interventionNames': ["Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP 2', 'description': "A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 2 response of 4 in TOF mode (Train Of Four)", 'interventionNames': ["Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP 3', 'description': "A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 3 response of 4 in TOF mode (Train Of Four)", 'interventionNames': ["Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP 4', 'description': "A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 4 response of 4 in TOF mode (Train Of Four)", 'interventionNames': ["Drug: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL', 'description': 'A control group : not receiving an antagonist (spontaneous recovery)', 'interventionNames': ['Other: Spontaneous recovery']}], 'interventions': [{'name': "Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery", 'type': 'DRUG', 'armGroupLabels': ['GROUP 1', 'GROUP 2', 'GROUP 3', 'GROUP 4']}, {'name': 'Spontaneous recovery', 'type': 'OTHER', 'description': 'just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio', 'armGroupLabels': ['CONTROL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Bruxelles Capitale', 'country': 'Belgium', 'facility': 'Michel Baurain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Libre de Bruxelles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'JOHN NICOLARDOT', 'investigatorAffiliation': 'Université Libre de Bruxelles'}}}}