Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT00559468
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2007-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'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'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor recognizes the right of the investigators to publish, but all publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 7 days after sugammadex treatment', 'description': 'All randomized participants receiving study treatment are included.', 'eventGroups': [{'id': 'EG000', 'title': 'Sugammadex + Sevoflurane', 'description': 'After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 21, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sugammadex + Propofol', 'description': 'After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 21, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex + Sevoflurane', 'description': 'After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}, {'id': 'OG001', 'title': 'Sugammadex + Propofol', 'description': 'After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 minutes after sugammadex administration', 'description': 'Neuromuscular functioning was monitored by applying repetitive Train of Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \\[loss of T4\\] up to 1.0 \\[no NMB\\]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached \\>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received sugammadex and had at least one efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex + Sevoflurane', 'description': 'After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}, {'id': 'OG001', 'title': 'Sugammadex + Propofol', 'description': 'After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 minutes after sugammadex administration', 'description': 'Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \\[loss of T4\\] up to 1.0 \\[no NMB\\]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.7 indicates a faster recovery from NMB.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received sugammadex and had at least one efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex + Sevoflurane', 'description': 'After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}, {'id': 'OG001', 'title': 'Sugammadex + Propofol', 'description': 'After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 minutes after sugammadex administration', 'description': 'Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \\[loss of T4\\] up to 1.0 \\[no NMB\\]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.8 indicates a faster recovery from NMB.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received sugammadex and had at least one efficacy measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sugammadex + Sevoflurane', 'description': 'After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}, {'id': 'FG001', 'title': 'Sugammadex + Propofol', 'description': 'After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants who had a surgical procedure using a general anesthesia (with sevoflurane or propofol) and rocuronium for endotracheal intubation and maintenance of neuromuscular block (NMB) were enrolled in this study.', 'preAssignmentDetails': 'Out of 52 randomized participants, 51 received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sugammadex + Sevoflurane', 'description': 'After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}, {'id': 'BG001', 'title': 'Sugammadex + Propofol', 'description': 'After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '50.1', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline analysis population includes all randomized participants receiving study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2007-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2007-11-14', 'resultsFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-13', 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9', 'timeFrame': 'Up to 3 minutes after sugammadex administration', 'description': 'Neuromuscular functioning was monitored by applying repetitive Train of Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \\[loss of T4\\] up to 1.0 \\[no NMB\\]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached \\>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB.'}], 'secondaryOutcomes': [{'measure': 'Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7', 'timeFrame': 'Up to 3 minutes after sugammadex administration', 'description': 'Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \\[loss of T4\\] up to 1.0 \\[no NMB\\]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.7 indicates a faster recovery from NMB.'}, {'measure': 'Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8', 'timeFrame': 'Up to 3 minutes after sugammadex administration', 'description': 'Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \\[loss of T4\\] up to 1.0 \\[no NMB\\]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.8 indicates a faster recovery from NMB.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia, General']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '19512873', 'type': 'RESULT', 'citation': 'Rex C, Wagner S, Spies C, Scholz J, Rietbergen H, Heeringa M, Wulf H. Reversal of neuromuscular blockade by sugammadex after continuous infusion of rocuronium in patients randomized to sevoflurane or propofol maintenance anesthesia. Anesthesiology. 2009 Jul;111(1):30-5. doi: 10.1097/ALN.0b013e3181a51cb0.'}], 'seeAlsoLinks': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'label': 'Click here to access a synopsis of the study results.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants at least 20 years but under 65 years of age;\n* Participants of American Society of Anesthesiologists (ASA) class 1-3;\n* Participants scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an anticipated duration of surgery between 2 and 5 hours;\n* Participants scheduled for a surgical procedure in supine position;\n* Participants who had given written informed consent.\n\nExclusion Criteria:\n\n* Participants in whom difficult intubation was expected because of anatomical malformations;\n* Participants known or suspected to have neuromuscular disorders affecting NMB and/or significant renal dysfunction. In Germany, this also included serum creatinine and blood urea nitrogen outside local reference ranges;\n* Participants known or suspected to have a (family) history of malignant hyperthermia;\n* Participants known or suspected to have an allergy to medications used during general anesthesia;\n* Participants receiving medication interfering with NMBAs, such as antibiotics, anticonvulsants and Mg\\^2+; based on the dose and time of administration;\n* Pregnant or lactating females;\n* Female participants of childbearing potential not using any birth control or using only hormonal contraception as birth control;\n* Participants who had already participated in trial CT 19.4.312, or in another trial with sugammadex;\n* Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into CT 19.4.312.'}, 'identificationModule': {'nctId': 'NCT00559468', 'briefTitle': 'Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multi -Center, Randomized, Parallel Group, Safety Assessor Blinded Trial Comparing Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex , Administered at T1 3-10% After Continuous Infusion of Rocuronium, and Pharmacokinetics of Rocuronium, Between Subjects Receiving Maintenance Anesthesia Using Propofol and Subjects Receiving Maintenance Anesthesia Using Sevoflurane', 'orgStudyIdInfo': {'id': 'P05949'}, 'secondaryIdInfos': [{'id': '19.4.312', 'type': 'OTHER', 'domain': 'Organon Protocol Number'}, {'id': 'MK-8616-028', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': '2006-004072-12', 'type': 'OTHER', 'domain': 'EudraCT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugammadex + Sevoflurane', 'description': 'After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.', 'interventionNames': ['Drug: Sugammadex', 'Drug: Rocuronium', 'Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Sugammadex + Propofol', 'description': 'After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.', 'interventionNames': ['Drug: Sugammadex', 'Drug: Rocuronium', 'Drug: Propofol']}], 'interventions': [{'name': 'Sugammadex', 'type': 'DRUG', 'otherNames': ['Org 25969', 'MK-8616'], 'description': 'Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium', 'armGroupLabels': ['Sugammadex + Propofol', 'Sugammadex + Sevoflurane']}, {'name': 'Rocuronium', 'type': 'DRUG', 'otherNames': ['Esmeron®', 'Rocuronium Bromide'], 'description': 'Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium', 'armGroupLabels': ['Sugammadex + Propofol', 'Sugammadex + Sevoflurane']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Ultane®'], 'description': 'Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.', 'armGroupLabels': ['Sugammadex + Sevoflurane']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan®'], 'description': 'Propofol IV administered for induction and maintenance of anesthesia, based on randomization.', 'armGroupLabels': ['Sugammadex + Propofol']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}