Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-29 @ 6:23 PM
Study NCT ID:
NCT06987357
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Sugammadex and Neostigmine on Early Extubation, Intensive Care Unit Admission and Length of Stay, and Hospital Costs in Adult Cranial Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of cost in the hospital process', 'timeFrame': 'through study completion, an average of 3 month'}, {'measure': 'Length of stay in the intensive care unit', 'timeFrame': 'through study completion, an average of 3 month'}, {'measure': 'Early extubation rate after two different neuromuscular blocking antagonist drugs', 'timeFrame': 'through study completion, an average of 3 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Craniectomy', 'Sugammadex', 'Extubation', 'Recovery After Neuromuscular Block', 'Hospital Costs']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to retrospectively investigate the effects of sugammadex or neostigmine, which are routinely used after the completion of surgery to antagonize (reverse) neuromuscular blockade in adult patients undergoing cranial surgery under general anesthesia, on early extubation in the operating room, intensive care unit admission and length of stay, length of hospital stay, and hospital costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Among the patients who underwent cranial surgery under sevoflurane anesthesia and whose neuromuscular blockade was provided with rocuronium, the patients whose neuromuscular blockade was antagonized with neostigmine or sugammadex and who were admitted to the intensive care unit postoperatively were evaluated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from the American Society of Anesthesiology (ASA) I-II-III group,\n* over the age of 18,\n* who underwent elective surgery,\n* underwent general anesthesia with sevoflurane anesthesia from volatile anesthetics,\n* used rocuronium as a neuromuscular blocking agent\n\nExclusion Criteria:\n\n* Patients aged 18 and under,\n* ASA IV and above,\n* who underwent surgery under emergency conditions,\n* who have incomplete follow-up form records and electronic media data,\n* who were taken to the intensive care unit without neuromuscular blockade antagonism due to long surgery,\n* who were treated with a neuromuscular blocking agent other than rocuronium,\n* who were treated with a volatile anesthetic other than sevoflurane or with total intravenous anesthesia.'}, 'identificationModule': {'nctId': 'NCT06987357', 'briefTitle': 'Comparison of the Effects of Sugammadex and Neostigmine on Early Extubation, Intensive Care Unit Admission and Length of Stay, and Hospital Costs in Adult Cranial Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Comparison of the Effects of Sugammadex and Neostigmine on Early Extubation, Intensive Care Unit Admission and Length of Stay, and Hospital Costs in Adult Cranial Surgery', 'orgStudyIdInfo': {'id': 'KAEK/2021.04.116'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group Neostigmine'}, {'label': 'Group Sugammadex'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Suleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Naime Yalçın', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}