Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-01 @ 3:00 PM
Study NCT ID:
NCT06745492
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2024-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Neostigmine at TOF Ratio of 0.7 Improves Neuromuscular Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery time', 'timeFrame': 'During surgery', 'description': 'Time from neostigmine administration to TOF ratio of 1.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recovery Time']}, 'descriptionModule': {'briefSummary': 'This study is a prospective observational study. A total of 54 patients were included in this study. We observed the time from neostigmine administration to TOF ratio of 1.0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective thyroid surgery under general anesthesia were screened and included in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective thyroid surgery under general anesthesia\n* a body mass index of 18.5-25 kg/m2\n* Age ≥ 20\n\nExclusion Criteria:\n\n* Refused to participate\n* history of hypersensitivity to acetylcholinesterase inhibitor\n* neuromuscular disease\n* hepatic or renal dysfunction'}, 'identificationModule': {'nctId': 'NCT06745492', 'briefTitle': 'Low-dose Neostigmine at TOF Ratio of 0.7 Improves Neuromuscular Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Low-dose Neostigmine at TOF Ratio of 0.7 Accelerates Neuromuscular Recovery Without Adverse Effects: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Neostigmine & TOFR 0.7'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neostigmine + Glycopyrrolate', 'type': 'DRUG', 'description': 'a 20 mcg/kg of neostigmine and 4 mcg/kg of glycopyrrolate were administered at a TOF ratio of 0.7.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'Chang-Hoon Koo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chang-Hoon Koo', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}