Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-02 @ 1:08 PM
Study NCT ID:
NCT03322657
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2017-10-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D000077122', 'term': 'Sugammadex'}], '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'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'FARAGE@ccf.org', 'phone': '216 444-7550', 'title': 'Dr. Ehab Farag', 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Until hospital discharge or 30 days after surgery, which came first', 'eventGroups': [{'id': 'EG000', 'title': 'Neostigmine With Glycopyrrolate', 'description': 'Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery\n\nNeostigmine: Neostigmine injection\n\nGlycopyrrolate: Glycopyrrolate injection', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sugammadex', 'description': 'Sugammadex 4 mg/kg at the end surgery\n\nSugammadex: Sugammadex injection', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine With Glycopyrrolate', 'description': 'Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery\n\nNeostigmine: Neostigmine injection\n\nGlycopyrrolate: Glycopyrrolate injection'}, {'id': 'OG001', 'title': 'Sugammadex', 'description': 'Sugammadex 4 mg/kg at the end surgery\n\nSugammadex: Sugammadex injection'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '2.2', 'ciUpperLimit': '6.5', 'statisticalMethod': 'Cox proportional hazard model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'within 90 minutes after endotracheal extubation', 'description': 'The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'TOF Ratio at 90 Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine With Glycopyrrolate', 'description': 'Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery\n\nNeostigmine: Neostigmine injection\n\nGlycopyrrolate: Glycopyrrolate injection'}, {'id': 'OG001', 'title': 'Sugammadex', 'description': 'Sugammadex 4 mg/kg at the end surgery\n\nSugammadex: Sugammadex injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1.14'}, {'value': '1.16', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '1.26'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.3', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '14', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'at 90 minutes after the administration of the reversal agent', 'description': 'TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board.\n\nOur primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eight patients were removed due to missing TOF at 90 min or TOF count not larger than 4.'}, {'type': 'SECONDARY', 'title': 'The Time for Extubation After Administration of Reversal Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine With Glycopyrrolate', 'description': 'Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery\n\nNeostigmine: Neostigmine injection\n\nGlycopyrrolate: Glycopyrrolate injection'}, {'id': 'OG001', 'title': 'Sugammadex', 'description': 'Sugammadex 4 mg/kg at the end surgery\n\nSugammadex: Sugammadex injection'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '11'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.34', 'statisticalMethod': 'Cox proportional hazard model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 hours after administration of reversal agents', 'description': 'Time from administration of reversal agent to tracheal extubation', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine With Glycopyrrolate', 'description': 'Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery\n\nNeostigmine: Neostigmine injection\n\nGlycopyrrolate: Glycopyrrolate injection'}, {'id': 'OG001', 'title': 'Sugammadex', 'description': 'Sugammadex 4 mg/kg at the end surgery\n\nSugammadex: Sugammadex injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '1.00', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 90 minutes after the administration of the reversal agent', 'description': 'The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 6 (17%) missing in sugammadex group and 5 (15%) missing in neostigmine group on diaphragmatic function outcomes.'}, {'type': 'SECONDARY', 'title': 'Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine With Glycopyrrolate', 'description': 'Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery\n\nNeostigmine: Neostigmine injection\n\nGlycopyrrolate: Glycopyrrolate injection'}, {'id': 'OG001', 'title': 'Sugammadex', 'description': 'Sugammadex 4 mg/kg at the end surgery\n\nSugammadex: Sugammadex injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '1.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '1.81', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 90 minutes after the administration of reversal agent', 'description': 'The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 6 (17%) missing in sugammadex group and 5 (15%) missing in neostigmine group on diaphragmatic function outcomes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neostigmine With Glycopyrrolate', 'description': 'Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery\n\nNeostigmine: Neostigmine injection\n\nGlycopyrrolate: Glycopyrrolate injection'}, {'id': 'FG001', 'title': 'Sugammadex', 'description': 'Sugammadex 4 mg/kg at the end surgery\n\nSugammadex: Sugammadex injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Neostigmine With Glycopyrrolate', 'description': 'Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery\n\nNeostigmine: Neostigmine injection\n\nGlycopyrrolate: Glycopyrrolate injection'}, {'id': 'BG001', 'title': 'Sugammadex', 'description': 'Sugammadex 4 mg/kg at the end surgery\n\nSugammadex: Sugammadex injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '12', 'groupId': 'BG000'}, {'value': '54', 'spread': '15', 'groupId': 'BG001'}, {'value': '56', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Afirican American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '90', 'spread': '32', 'groupId': 'BG000'}, {'value': '92', 'spread': '38', 'groupId': 'BG001'}, {'value': '91', 'spread': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA', 'classes': [{'title': 'II', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "American Society of Anesthesiologists physical status is to assess and communicate a patient's pre-anesthesia medical co-morbidities. This status has a grade from I to VI, where I mean a normal healthy patient and VI means a declared brain-dead patient whose organs are being removed for donor purposes.", 'unitOfMeasure': 'Participants'}, {'title': 'Arterial hypertension', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Asthma', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic pulmonary disease', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Obstructive sleep apnea', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes mellitus', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Myocardial infarction', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ischemic heart disease', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Neurologic diseases', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic pain requiring opioids', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current smoker', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current recreational drug user', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol abuse', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'No medical history', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intraoperative remifentanil', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intraoperative remifentanil use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'Participants'}, {'title': 'Intraoperative remifentanil, μg', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '542'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '444'}]}]}], 'paramType': 'MEDIAN', 'description': 'Intraoperative remifentanil use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'μg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Intraoperative fentanyl', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intraoperative fentanyl use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'Participants'}, {'title': 'Intraoperative fentanyl, mg', 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'BG000', 'lowerLimit': '0.07', 'upperLimit': '0.12'}, {'value': '0.10', 'groupId': 'BG001', 'lowerLimit': '0.09', 'upperLimit': '0.15'}, {'value': '0.10', 'groupId': 'BG002', 'lowerLimit': '0.08', 'upperLimit': '0.15'}]}]}], 'paramType': 'MEDIAN', 'description': 'Intraoperative fentanyl use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Intraoperative propofol, mg', 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000', 'lowerLimit': '150', 'upperLimit': '230'}, {'value': '200', 'groupId': 'BG001', 'lowerLimit': '150', 'upperLimit': '242'}, {'value': '200', 'groupId': 'BG002', 'lowerLimit': '150', 'upperLimit': '241'}]}]}], 'paramType': 'MEDIAN', 'description': 'Intraoperative propofol use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Intraoperative midazolam, mg', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'Intraoperative midazolam use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Intraoperative Phenylephrine', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intraoperative phenylephrine use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'Participants'}, {'title': 'Intraoperative Ephedrine', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intraoperative ephedrine use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'Participants'}, {'title': 'Intraoperative Norepinephrine', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intraoperative norepinephrine use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'Participants'}, {'title': 'Time-weighted average minimum alveolar concentration', 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'groupId': 'BG000', 'lowerLimit': '0.68', 'upperLimit': '0.88'}, {'value': '0.78', 'groupId': 'BG001', 'lowerLimit': '0.69', 'upperLimit': '0.87'}, {'value': '0.78', 'groupId': 'BG002', 'lowerLimit': '0.69', 'upperLimit': '0.88'}]}]}], 'paramType': 'MEDIAN', 'description': 'time-weighted average minimum alveolar concentration could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures.', 'unitOfMeasure': 'percent at 1 atmosphere', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-17', 'size': 250673, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-12T09:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2017-10-13', 'resultsFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2017-10-25', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-12', 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent', 'timeFrame': 'within 90 minutes after endotracheal extubation', 'description': 'The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent.'}, {'measure': 'TOF Ratio at 90 Min', 'timeFrame': 'at 90 minutes after the administration of the reversal agent', 'description': 'TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board.\n\nOur primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis.'}], 'secondaryOutcomes': [{'measure': 'The Time for Extubation After Administration of Reversal Agents', 'timeFrame': 'Up to 4 hours after administration of reversal agents', 'description': 'Time from administration of reversal agent to tracheal extubation'}, {'measure': 'Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s', 'timeFrame': 'from baseline to 90 minutes after the administration of the reversal agent', 'description': 'The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.'}, {'measure': 'Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s', 'timeFrame': 'from baseline to 90 minutes after the administration of reversal agent', 'description': 'The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sugammadex', 'Neostigmine', 'Reversal of neuromuscular block'], 'conditions': ['Neuromuscular Blockade', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '34032663', 'type': 'DERIVED', 'citation': 'Farag E, Rivas E, Bravo M, Hussain S, Argalious M, Khanna S, Seif J, Pu X, Mao G, Bain M, Elgabaly M, Esa WAS, Sessler DI. Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-Based Neurointerventional Procedures: A Randomized Trial. Anesth Analg. 2021 Jun 1;132(6):1666-1676. doi: 10.1213/ANE.0000000000005533.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.', 'detailedDescription': 'Incomplete recovery from neuromuscular blocking agents (NMBAs) residual block after anesthesia and surgery continues to be a common problem in the postanesthesia care (PACU).\n\nNeostigmine remains the most common acetylcholinesterase inhibitor in the United States. However, administration of the drug significantly impairs genioglossus muscle activity when administered after full recovery from neuromuscular block. Moreover, doses of neostigmine exceeding 0.06 mg/kg increase the risk of respiratory complications independent of NMBAs effects.\n\nSugammadex is a modified γ-cyclodextrin that rapidly reverses that effect of the steroidal nondepolarizing NMBAs rocuronium and vecuronium. Sugammadex forms a stable, inactive 1:1 complex with rocuronium or vecuronium, reducing the amount of free NMBA available to bind to nicotinic acetylcholine receptors at the neuromuscular junction. Unlike neostigmine, sugammadex completely reverses even dense neuromuscular blocks.\n\nPatients having catheter-based neurointerventional procedures are kept deeply anesthetized. It is common to find patients nearly completely paralyzed at the end of neurointerventional procedures and have a markedly delayed emergence while waiting for muscle function to recover sufficiently to safely antagonize with neostigmine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* American Society of Anesthesiologists (ASA) physical status 1-3;\n* Scheduled for catheter-based neurointerventional procedures including coiling and stent insertion;\n* General anesthesia.\n\nExclusion Criteria:\n\n* Suspected difficult intubation;\n* Neuromuscular disorder;\n* Renal impairment creatinine ≥ 2 mg /dl;\n* Hepatic dysfunction;\n* History of malignant hyperthermia;\n* Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;\n* Perioperative respiratory infections and/or pneumonia;\n* Intubated or unresponsive;\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03322657', 'briefTitle': 'Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures', 'orgStudyIdInfo': {'id': '17-764'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neostigmine with glycopyrrolate', 'description': 'Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery', 'interventionNames': ['Drug: Neostigmine', 'Drug: Glycopyrrolate']}, {'type': 'EXPERIMENTAL', 'label': 'Sugammadex', 'description': 'Sugammadex 4 mg/kg at the end surgery', 'interventionNames': ['Drug: Sugammadex']}], 'interventions': [{'name': 'Neostigmine', 'type': 'DRUG', 'description': 'Neostigmine injection', 'armGroupLabels': ['Neostigmine with glycopyrrolate']}, {'name': 'Glycopyrrolate', 'type': 'DRUG', 'description': 'Glycopyrrolate injection', 'armGroupLabels': ['Neostigmine with glycopyrrolate']}, {'name': 'Sugammadex', 'type': 'DRUG', 'description': 'Sugammadex injection', 'armGroupLabels': ['Sugammadex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ehab Farag, M.D.', 'investigatorFullName': 'Ehab Farag, MD', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}