Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
Study NCT ID:
NCT03857750
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2019-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neuromuscular Blocking Agents in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matiasvested@gmail.com', 'phone': '+4524464955', 'title': 'Dr. Matias Vested', 'organization': 'Rigshospitalet'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From induction of anesthesia to departure from the operating room.', 'description': 'In both groups the patients will receive rocuronium in a dose aiming to provide optimal intubating conditions. It is not regarded as a disadvantage to use rocuronium, since the effect is monitored through surgery and if needed fully reversed by a reversal agent upon end of surgery.\n\nIt is an observational study why the patients mortality was not affected by the trial. Furthermore, patients at high risk for serious adverse events were excluded due to the criteria.', 'eventGroups': [{'id': 'EG000', 'title': 'Elderly (>80 Years)', 'description': '16 patients planned for elective surgery above 80 years\n\nRocuronium: 0.6 mg/kg', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Younger (18-40 Years)', 'description': '16 patients planned for elective surgery between 18-40 years\n\nRocuronium: 0.6 mg/kg', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0.01'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Onset Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elderly (>80 Years)', 'description': '16 patients planned for elective surgery above 80 years\n\nRocuronium: 0.6 mg/kg'}, {'id': 'OG001', 'title': 'Younger (18-40 Years)', 'description': '16 patients planned for elective surgery between 18-40 years\n\nRocuronium: 0.6 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000', 'lowerLimit': '135', 'upperLimit': '158'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '105'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '82', 'ciLowerLimit': '40', 'ciUpperLimit': '124', 'groupDescription': 'Comparing onset time of rocuronium', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.48', 'estimateComment': '95 % confidence interval is 7.63 to infinity', 'groupDescription': '82', 'statisticalMethod': 'Wilcoxon Mann-Whitney odd', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0, after induction of anesthesia', 'description': 'The time from the end of rocuronium injection to train-of-four (TOF) count of 0 monitored by acceleromyography.\n\nThe ulnar nerve was stimulated during the monitoring.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comparing Intubating Conditions in the Two Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elderly (>80 Years)', 'description': '16 patients planned for elective surgery above 80 years\n\nRocuronium: 0.6 mg/kg'}, {'id': 'OG001', 'title': 'Younger (18-40 Years)', 'description': '16 patients planned for elective surgery between 18-40 years\n\nRocuronium: 0.6 mg/kg'}], 'classes': [{'categories': [{'title': 'Easy', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Slight', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Moderate/Major', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0, after induction of anesthesia', 'description': '90 seconds after induction the conditions are rated by the Intubating Difficulty Scale (IDS).\n\nEasy is defined as IDS of 0. Slight is defined as IDS of 1 to 5 Moderate/Major is defined as \\>5', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Action', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elderly (>80 Years)', 'description': '16 patients planned for elective surgery above 80 years\n\nRocuronium: 0.6 mg/kg'}, {'id': 'OG001', 'title': 'Younger (18-40 Years)', 'description': '16 patients planned for elective surgery between 18-40 years\n\nRocuronium: 0.6 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '97'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '73'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31', 'ciLowerLimit': '14', 'ciUpperLimit': '48', 'groupDescription': 'Comparing duration of action of rocuronium', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6.35', 'estimateComment': '95% Confidence interval is 2.59 to infinity.', 'groupDescription': 'Comparing duration of action of rocuronium', 'statisticalMethod': 'Wilcoxon Mann-Whitney odd', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0, after induction of anesthesia', 'description': 'Time from end of rocuronium injection to TOF ratio \\>0.9. When the ratio between the first and last stimulation in TOF is above 90 %.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '3 in each group had missing data due to supplementary doses of rocuronium'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Elderly (>80 Years)', 'description': '16 patients planned for elective surgery above 80 years\n\nRocuronium: 0.6 mg/kg'}, {'id': 'FG001', 'title': 'Younger (18-40 Years)', 'description': '16 patients planned for elective surgery between 18-40 years\n\nRocuronium: 0.6 mg/kg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were included from the Departments of Anaesthesia, Centre of Head and Orthopaedics and Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Denmark in the period of the 27th of March 2019 to 7th of November 2019.', 'preAssignmentDetails': 'Five of 37 patients were excluded due to rescheduling, rapid sequence induction, prone position and different anesthetic medication. 3 patients in each group have missing data on duration of action due to supplementary doses of rocuronium.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Elderly (>80 Years)', 'description': '16 patients planned for elective surgery above 80 years\n\nRocuronium: 0.6 mg/kg'}, {'id': 'BG001', 'title': 'Younger (18-40 Years)', 'description': '16 patients planned for elective surgery between 18-40 years\n\nRocuronium: 0.6 mg/kg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000', 'lowerLimit': '81', 'upperLimit': '85'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '34'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '31', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000', 'lowerLimit': '160', 'upperLimit': '167'}, {'value': '174', 'groupId': 'BG001', 'lowerLimit': '170', 'upperLimit': '179'}, {'value': '169', 'groupId': 'BG002', 'lowerLimit': '164', 'upperLimit': '174'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '79.8'}, {'value': '72.5', 'groupId': 'BG001', 'lowerLimit': '66', 'upperLimit': '78.5'}, {'value': '73.5', 'groupId': 'BG002', 'lowerLimit': '62.5', 'upperLimit': '79.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'ASA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'title': 'ASA I', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'ASA II', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'ASA III', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'American Society of Anesthesiologists physical status was used to investigate if the two groups were similar concerning comorbidities.\n\nASA 1: no riskfactors or comorbidities ASA 2: slight riskfactors or/and comorbidites ASA 3: moderate riskfactors or/and comorbidities', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'Heart disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Liver disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Renal disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medication', 'classes': [{'title': 'Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Loop-diuretics or thiazids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of anesthesia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000', 'lowerLimit': '127', 'upperLimit': '194'}, {'value': '146', 'groupId': 'BG001', 'lowerLimit': '128', 'upperLimit': '189'}, {'value': '154', 'groupId': 'BG002', 'lowerLimit': '127', 'upperLimit': '194'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Duration of surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000', 'lowerLimit': '69', 'upperLimit': '113'}, {'value': '101', 'groupId': 'BG001', 'lowerLimit': '77', 'upperLimit': '132'}, {'value': '102', 'groupId': 'BG002', 'lowerLimit': '74', 'upperLimit': '125'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-06', 'size': 318760, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-25T05:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2019-02-25', 'resultsFirstSubmitDate': '2020-01-27', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-18', 'studyFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset Time', 'timeFrame': 'Day 0, after induction of anesthesia', 'description': 'The time from the end of rocuronium injection to train-of-four (TOF) count of 0 monitored by acceleromyography.\n\nThe ulnar nerve was stimulated during the monitoring.'}], 'secondaryOutcomes': [{'measure': 'Comparing Intubating Conditions in the Two Groups', 'timeFrame': 'Day 0, after induction of anesthesia', 'description': '90 seconds after induction the conditions are rated by the Intubating Difficulty Scale (IDS).\n\nEasy is defined as IDS of 0. Slight is defined as IDS of 1 to 5 Moderate/Major is defined as \\>5'}, {'measure': 'Duration of Action', 'timeFrame': 'Day 0, after induction of anesthesia', 'description': 'Time from end of rocuronium injection to TOF ratio \\>0.9. When the ratio between the first and last stimulation in TOF is above 90 %.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elective Surgery']}, 'referencesModule': {'references': [{'pmid': '38847412', 'type': 'DERIVED', 'citation': 'Wadland SS, Rasmussen LS, Vested M. Shortened time to neuromuscular recovery with lower doses of rocuronium in elderly patients. Dan Med J. 2024 May 13;71(6):A09230578. doi: 10.61409/A09230578.'}, {'pmid': '32462665', 'type': 'DERIVED', 'citation': 'Bjerring C, Vested M, Arleth T, Eriksen K, Albrechtsen C, Rasmussen LS. Onset time and duration of action of rocuronium 0.6 mg/kg in patients above 80 years of age: A comparison with young adults. Acta Anaesthesiol Scand. 2020 Sep;64(8):1082-1088. doi: 10.1111/aas.13645. Epub 2020 Jun 18.'}]}, 'descriptionModule': {'briefSummary': 'The number of elderly patients (\\>80 years) is increasing and a large proportion of these patients will require surgery and anaestheasia within the next decades.\n\nDuring anaesthesia NMBAs are used to facilitate tracheal intubation, from former studies it is reported that elderly patients are more sensitive towards muscle relaxants.\n\nIt is unknown if there are differences in onset times of NMBAs between younger patients and elderly.\n\nThe aim of this study is to determine the onset time, duration of action and effect on intubating conditions for rocuronium 0.6 mg/kg in patients aged 18-40 years and in patiens \\>80 years. The hypothesis of this study is that rocuronium administered in elderly patients (\\>80 years) has a longer onset time compared to younger patients.', 'detailedDescription': 'The number of elderly patients (\\>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia within the next decades. Elderly patients are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia as for example neuromuscular blocking agents (NMBA).\n\nDuring anesthesia NMBAs are used to facilitate tracheal intubation, establish muscle relaxation and suppress reflexes during surgery. Elderly patients are more sensitive towards muscle relaxants. In addition studies have reported prolonged duration of NMBAs and an observational study found that elderly patients are more prone to experience residual neuromuscular blockade in the post anesthesia care unit. However, most studies have been conducted in elderly below 80 years.\n\nIt is unknown if there are differences in onset times of NMBAs e.g. rocuronium, mivacurium and cisatracurium between younger patients and elderly. Onset time for NMBAs in the elderly is of importance since it may influence intubating conditions, especially during rapid sequence induction. For example it is unknown in the elderly if an increased dose of NMBA reduces the onset time. There remains a need for studies investigating the optimal dose for facilitating intubation in the elderly, both during rapid sequence induction and during elective procedures.\n\nThe aim of this study is to determine the onset time, duration of action and effect on intubating conditions for rocuronium 0.6 mg/kg in patients aged 18-40 years and in patients with age \\> 80 years. The hypothesis of this study is that rocuronium administered in elderly patients (\\>80 years) has a longer onset in the elderly compared to younger patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '32 patients Group young: 16 patients age between 18-40 years receiving rocuronium 0.6 mg/kg Group elderly: 16 patients age \\>80 years receiving rocuronium 0.6 mg/kg', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years old\n* Informed consent\n* Scheduled for elective surgery (\\>1 hour) under general anaesthesia with intubation and use of rocuronium.\n* American Society of Anaesthesiologists (ASA) physical status classification I to III\n* Can read and understand Danish\n\nExclusion Criteria:\n\n* Known allergy to rocuronium\n* Neuromuscular disease that may interfere with neuromuscular data\n* Indication for rapid sequence induction'}, 'identificationModule': {'nctId': 'NCT03857750', 'briefTitle': 'Neuromuscular Blocking Agents in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'An Observational Study of Rocuronium 0.6 mg/kg Comparing Onset Time, Duration of Action and Effect on Intubation Conditions in Younger (18 - 40 Years) and Elderly Patients (> 80 Years)', 'orgStudyIdInfo': {'id': 'H-18063017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly (>80 years)', 'description': 'Patients planned for elective surgery above 80 years', 'interventionNames': ['Drug: Rocuronium']}, {'label': 'Younger (18-40 years)', 'description': 'Patients planned for elective surgery between 18-40 years', 'interventionNames': ['Drug: Rocuronium']}], 'interventions': [{'name': 'Rocuronium', 'type': 'DRUG', 'otherNames': ['Rocuronium 0.6 mg/kg'], 'description': '0.6 mg/kg', 'armGroupLabels': ['Elderly (>80 years)', 'Younger (18-40 years)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Matias Vested, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Medical Doctor, PhD', 'investigatorFullName': 'Matias Vested', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}