Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT01890057
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2013-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Dose of Sugammadex for Rapid Reversal of Profound Neuromuscular Block in Young and Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-02', 'studyFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block', 'timeFrame': '2 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia Recovery Period, Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': 'To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound rocuronium-induced neuromuscular block in young and elderly adult patients.', 'detailedDescription': 'A previous study reported that elderly patients required a longer time to recover from rocuronium induced neuromuscular block compared to younger patients. Therefore, the aim of this study is to find out the dose of sugammadex for rapid recovery from profound neuromuscular block in young and elderly adult patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-40 years or ≥70 years ASA class I-II patients who received surgery less than 2 hours.\n\nExclusion Criteria:\n\n* anticipated difficult intubation\n* neuromuscular, hepatic or renal disorders\n* drug allergy\n* body mass index \\>30 kg/m2 or body mass index \\<18 kg/m2\n* emergency surgery'}, 'identificationModule': {'nctId': 'NCT01890057', 'briefTitle': 'The Dose of Sugammadex for Rapid Reversal of Profound Neuromuscular Block in Young and Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Severance Hospital'}, 'orgStudyIdInfo': {'id': '4-2013-0280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Young adults', 'description': "To find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method", 'interventionNames': ['Drug: Sugammadex']}, {'type': 'EXPERIMENTAL', 'label': 'Elderly adults', 'description': "To find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method", 'interventionNames': ['Drug: Sugammadex']}], 'interventions': [{'name': 'Sugammadex', 'type': 'DRUG', 'description': 'The dose of sugammadex', 'armGroupLabels': ['Elderly adults', 'Young adults']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'So Yeon Kim', 'investigatorAffiliation': 'Severance Hospital'}}}}