Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT06072534
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077590', 'term': 'Mivacurium'}], 'ancestors': [{'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized double blind'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2023-09-03', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation conditions during RSI.', 'timeFrame': '3 months', 'description': "Jaw relaxation or ease blade insertion was graded as easy (3), moderate (2), difficult (1) and impossible (0).\n\nVocal cord positions were ranked as abducted (3), moving (2), closing (1) and closed (0). Response to intubation was graded as no movement (3), slight diaphragmatic movement (2), mild coughing (1) and severe coughing or bucking (0).\n\nThe total scores of the three variables were rated as excellent (8-9), good (6-7), fair (3-5) and poor (0-2).\n\nGood and excellent intubating conditions were considered 'clinically acceptable'."}], 'secondaryOutcomes': [{'measure': 'change in heart rate beat/minute:', 'timeFrame': '12 weeks', 'description': '* pre-induction.\n* every 1 minute for 5 minutes after intubation'}, {'measure': 'change in mean arterial bood pressure (MAP) mmHg/minute:', 'timeFrame': '12 weeks', 'description': '* pre-induction.\n* every 1 minute for 5 minutes after intubating'}, {'measure': 'time/minute to T1 recovery monitoring', 'timeFrame': '12 weeks', 'description': 'by train-of-four (TOF) every 5 minutes until one twitch of TOF'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mivacurium', 'rapid sequence intubation', 'emergency surgery'], 'conditions': ['Emergencies']}, 'referencesModule': {'references': [{'pmid': '2967039', 'type': 'BACKGROUND', 'citation': 'Savarese JJ, Ali HH, Basta SJ, Embree PB, Scott RP, Sunder N, Weakly JN, Wastila WB, el-Sayad HA. The clinical neuromuscular pharmacology of mivacurium chloride (BW B1090U). A short-acting nondepolarizing ester neuromuscular blocking drug. Anesthesiology. 1988 May;68(5):723-32. doi: 10.1097/00000542-198805000-00010.'}, {'pmid': '14616318', 'type': 'BACKGROUND', 'citation': 'Ostergaard D, Viby-Mogensen J, Rasmussen SN, Gatke MR, Pedersen NA, Skovgaard LT. Pharmacokinetics and pharmacodynamics of mivacurium in patients phenotypically heterozygous for the usual and atypical plasma cholinesterase variants (UA). Acta Anaesthesiol Scand. 2003 Nov;47(10):1219-25. doi: 10.1046/j.1399-6576.2003.00243.x.'}, {'pmid': '12145055', 'type': 'BACKGROUND', 'citation': 'Plaud B, Marty J, Debaene B, Meistelman C, Pellissier D, LePage JY, Feiss P, Scherpereel P, Bouverne MN, Fosse S. The cardiovascular effects of mivacurium in hypertensive patients. Anesth Analg. 2002 Aug;95(2):379-84, table of contents. doi: 10.1097/00000539-200208000-00025.'}, {'pmid': '1389845', 'type': 'BACKGROUND', 'citation': 'Cooper R, Mirakhur RK, Clarke RS, Boules Z. Comparison of intubating conditions after administration of Org 9246 (rocuronium) and suxamethonium. Br J Anaesth. 1992 Sep;69(3):269-73. doi: 10.1093/bja/69.3.269.'}]}, 'descriptionModule': {'briefSummary': 'Mivacurium can be considered as an optimal choice for muscle relaxation in short duration surgeries, as butyrylcholinesterase can rapidly and reliably degrade this benzylisoquinoline muscle relaxant in vivo. However the histamine release related to a rapid high-dose injection, unsatisfactory intubation conditions and unexpected delay in recovery in patients may be encountered with butyrylcholinesterase deficiency', 'detailedDescription': 'Intubation in emergency and full stomach patients stands as a challenge in anaesthesia. Rapid sequence induction (RSI) is the key player technique in avoiding gastric contents aspiration risk. Non-depolarizing neuromuscular blocking agents as mivacurium are of clinical significance in the anesthetic management of patient. Mivacurium has been has been preferred in situations who necessitating hemodynamic solidity all over the surgery, as only transient tachycardia and hypotension were recorded\n\nAim of work Using high doses of mivacurium can provide accepted condition of emergency intubation within favorable time - monitoring hemodynamics changes during and after intubation, time of recovery from high doses of muscle relaxant'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-60 year old patients.\n* American society of anaesthesia (ASA) 1 and 2.\n* Emergency surgery.\n\nExclusion Criteria:\n\n* Refusal.\n* allergy.\n* neuromuscular disease.\n* Suspected desaturation.\n* Severe cardiac disease.\n* Severe pulmonary disease.'}, 'identificationModule': {'nctId': 'NCT06072534', 'acronym': 'RSI', 'briefTitle': 'Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of Effectiveness of Two Different Doses of Mivacurium in Modified Rapid Sequence Intubation for Emergency Surgery ,Prospective Randomized Double Blind Study', 'orgStudyIdInfo': {'id': 'mivacurium in RSI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Miva 3', 'description': '"Mivacurium chloride" ("Mivacron®") 0.3 mg/kg 3 times effective dose (ED) 95 iv during induction recording intubation condition during rapid sequence intubation within 90 sc monitoring hemodynamic changes during intubation ,time to recover to T1', 'interventionNames': ['Drug: "Mivacurium Chloride"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Miva 4', 'description': '"Mivacurium chloride" ("Mivacron®") 0.4 mg/kg 4 times effective dose (ED) 95 iv during induction\n\nrecording intubation condition during rapid sequence intubation within 90 sc monitoring hemodynamic changes during intubation,time to recover to T1', 'interventionNames': ['Drug: "Mivacurium Chloride"']}], 'interventions': [{'name': '"Mivacurium Chloride"', 'type': 'DRUG', 'otherNames': ['"Mivacron®"'], 'description': 'emergence modified sequence intubation', 'armGroupLabels': ['Miva 3', 'Miva 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11811', 'city': 'Cairo', 'state': 'Naser City', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed m selim, director', 'role': 'CONTACT', 'email': 'info@azhar.edu.eg', 'phone': '0020222611404'}], 'facility': 'Al Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'ismail m ahmed, professor', 'role': 'CONTACT', 'email': 'ismailabdelgawad.623@azhar.edu.eg', 'phone': '00201117310053'}], 'overallOfficials': [{'name': 'ismail m ahmed, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the patient will be coded'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DOCTOR', 'investigatorFullName': 'Ismail Mohamed Abdelgawad Ahmed', 'investigatorAffiliation': 'Al-Azhar University'}}}}