Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-01 @ 9:13 AM
Study NCT ID:
NCT05760560
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2023-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2023-02-26', 'studyFirstSubmitQcDate': '2023-02-26', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative residual neuromuscular blockade', 'timeFrame': 'On the arrival of PACU', 'description': 'TOF ratio \\< 0.9'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Residual Curarization']}, 'referencesModule': {'references': [{'pmid': '39419348', 'type': 'DERIVED', 'citation': 'Koo CH, Lee S, Yim S, Bae YK, Park I, Oh AY. Is quantitative neuromuscular monitoring mandatory after administration of the recommended dose of sugammadex? A prospective observational study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101445. doi: 10.1016/j.accpm.2024.101445. Epub 2024 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective observational study. A total 52 patients will be included in this study. We will observe the incidence of postoperative residual neuromuscular blockade in patients receiving sugammadex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective surgery under general anesthesia will be screened and included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective surgery under general anesthesia.\n* American Society of Anesthesiologists grade 1, 2, or 3.\n* Aged \\>18 years\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Body Mass Index \\< 18.5 kg/m2 or \\> 35 kg/m2\n* History of neuromuscular disease.\n* History of allergy to neuromuscular blockade\n* Scheduled to transfer to the intensive care unit'}, 'identificationModule': {'nctId': 'NCT05760560', 'briefTitle': 'Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex', 'orgStudyIdInfo': {'id': 'TOF-Sugammadex'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sugammadex', 'type': 'DRUG', 'description': 'At the end of surgery, neuromucular blockade will be reversed with 2mg/kg or 4mg/kg sugammadex depending on the depth of neuromuscular blockade.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chang-Hoon Koo, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Chang-Hoon Koo', 'role': 'CONTACT', 'email': 'vollock9@gmail.com', 'phone': '+821085098841'}], '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': 'Assistant professor', 'investigatorFullName': 'Chang-Hoon Koo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}