Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05886218
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2023-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quantitative Neuromuscular Monitoring and Gastric Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-17', 'releaseDate': '2025-08-28'}], 'estimatedResultsFirstSubmitDate': '2025-08-28'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 215}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen desaturation', 'timeFrame': '24 hours', 'description': 'Incidence and magnitude of significant oxygen desaturation'}], 'secondaryOutcomes': [{'measure': 'The rate of compliance with muscle relaxant monitoring and reversal protocols', 'timeFrame': '24 hours', 'description': 'Rate of compliance (%)'}, {'measure': 'Total intraoperative rocuronium use', 'timeFrame': '24 hours', 'description': 'Total dose/kg/hr (mg/kg/hr)'}, {'measure': 'Total sugammadex dose', 'timeFrame': '24 hours', 'description': 'Total dose (mg/kg)'}, {'measure': 'Post-operative supplemental oxygen requirement', 'timeFrame': '24 hours', 'description': 'Oxygen requirement (FiO2%/hr)'}, {'measure': 'Post-operative unit length of stay', 'timeFrame': '7 days', 'description': 'Length of stay (Hours)'}, {'measure': 'Hospital Length of stay', 'timeFrame': '7 days', 'description': 'Length of stay (Hours)'}, {'measure': 'Success rate for wearable device', 'timeFrame': '24 hours', 'description': 'Rate of compliance (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sugammadex']}, 'descriptionModule': {'briefSummary': 'This is a single site, prospective, non-blinded, non-randomized, before/after study. This study is designed to evaluate the impact of monitoring and reversal guidelines for neuromuscular blocking drugs on the post-operative outcomes for patients undergoing laparoscopic gastric bypass surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for surgical procedures in the UC Davis Medical Center main ORs will be screened for potential enrollment.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age greater than 18 years\n* scheduled for an elective laparoscopic gastric bypass procedure\n\nExclusion Criteria:\n\n* age less than 18 years\n* pregnancy\n* prisoners\n* significant co-existing lung disease including asthma or chronic obstructive pulmonary disease (COPD) requiring regular medication\n* patients who require supplemental oxygen pre-operatively to maintain a hemoglobin saturation (SpO2\\>98%)'}, 'identificationModule': {'nctId': 'NCT05886218', 'briefTitle': 'Quantitative Neuromuscular Monitoring and Gastric Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'A Before/After Study of the Impact of Quantitative Neuromuscular Monitoring and Sugammadex Reversal Following Gastric Bypass Surgery', 'orgStudyIdInfo': {'id': '2004503'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Quantitative Neuromuscular Function Monitoring', 'type': 'DEVICE', 'description': 'Quantitative electromyographic (EMG) monitoring'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ana Arias', 'role': 'CONTACT', 'email': 'apaarias@ucdavis.edu', 'phone': '916-703-5456'}, {'name': 'Neal Fleming, MD, PhD', 'role': 'CONTACT', 'email': 'nwfleming@ucdavis.edu', 'phone': '916 734-5046'}], 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Ana P Arias, BS', 'role': 'CONTACT', 'email': 'apaarias@ucdavis.edu', 'phone': '916-703-5456'}, {'name': 'Julio J Arana Pineda, BA', 'role': 'CONTACT', 'email': 'jjaranapineda@ucdavis.edu', 'phone': '916-734-4074'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-28', 'type': 'RELEASE'}, {'date': '2025-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of California, Davis'}}}}