Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-02-24 @ 5:42 AM
Study NCT ID:
NCT03513406
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2018-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-22', 'mcpReleaseN': 6, 'releaseDate': '2024-09-27'}, {'resetDate': '2024-12-30', 'mcpReleaseN': 7, 'releaseDate': '2024-12-09'}, {'resetDate': '2025-02-05', 'mcpReleaseN': 8, 'releaseDate': '2025-01-14'}, {'resetDate': '2025-04-21', 'mcpReleaseN': 9, 'releaseDate': '2025-04-02'}], 'estimatedResultsFirstSubmitDate': '2024-09-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}], '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': '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2018-04-19', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to return to a 90% Train of Four (TOF) neuromuscular twitch', 'timeFrame': 'Within 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Time to endotracheal extubation', 'timeFrame': 'Within 24 hours after surgery'}, {'measure': 'Time to discharge from the operating room', 'timeFrame': 'Within 24 hours after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle function'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if there is a difference in recovery time when using sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to the safety of using sugammadex in burn patients who are hypermetabolic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing burn surgery under general anesthesia\n\nExclusion Criteria:\n\n* Patients without a non-burned upper extremity\n* Renal insufficiency or failure\n* Sensitivity or hypersensitivity reaction to sugammadex\n* Liver impairment, neuromuscular degenerative disease or dependence on drugs or alcohol'}, 'identificationModule': {'nctId': 'NCT03513406', 'briefTitle': 'Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery', 'orgStudyIdInfo': {'id': 'STUDY00141829'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sugammadex', 'description': 'Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV.', 'interventionNames': ['Drug: Sugammadex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neostigmine', 'description': 'Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV.', 'interventionNames': ['Drug: Neostigmine', 'Drug: Glycopyrrolate']}], 'interventions': [{'name': 'Sugammadex', 'type': 'DRUG', 'description': 'Sugammadex is indicated for the reversal of neuromuscular blockade.', 'armGroupLabels': ['Sugammadex']}, {'name': 'Neostigmine', 'type': 'DRUG', 'description': 'Neostigmine is indicated for the reversal of neuromuscular blockade.', 'armGroupLabels': ['Neostigmine']}, {'name': 'Glycopyrrolate', 'type': 'DRUG', 'description': "Glycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects.", 'armGroupLabels': ['Neostigmine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Anthony Kovac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}