Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-29 @ 10:50 PM
Study NCT ID:
NCT06805032
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-02
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy and Precision of Train-of-Four Ratios Obtained With Acceleromyography and Electromyography in Restricted-Movement Settings in the Absence of Neuromuscular Blocking Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy and precision', 'timeFrame': '120 minutes', 'description': 'Accuracy and precision of train-of-four ratios measured simultaneously by two quantitative neuromuscular monitors every minute among 40 patients undergoing surgery of at least 30 min duration (roughly 1200 measurements) in which the arms are tucked and in the absence of neuromuscular blocking agents. In the absence of neuromusuclar blocking agents, the expected train-of-four ratio is 1.0. Accuracy of each monitor will be assessed by how close measuremetns are to 1.0 while precision will be assessed by the variability of the measured responses in all patients undergoing procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystoscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to compare the performance of acceleromyograph and electromyograph-based quantitative neuromuscular monitors when the arms are tucked for surgical positioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective surgery and requiring general anesthesia without administration of neuromuscular blocking agents.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients willing to participate and provide an informed consent.\n* Patients undergoing elective surgical procedures that require general anesthesia without use of NMBA agents administered intraoperatively, and tucked arms.\n* Anticipated surgery duration \\< 120 minutes.\n\nExclusion Criteria:\n\n* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.\n* Patients with systemic neuromuscular diseases such as myasthenia gravis.\n* Patients having surgery that would involve prepping the arm into the sterile field.'}, 'identificationModule': {'nctId': 'NCT06805032', 'briefTitle': 'Accuracy and Precision of Train-of-Four Ratios Obtained With Acceleromyography and Electromyography in Restricted-Movement Settings in the Absence of Neuromuscular Blocking Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Accuracy and Precision of Train-of-Four Ratios Obtained With Acceleromyography and Electromyography in Restricted-Movement Settings in the Absence of Neuromuscular Blocking Drugs', 'orgStudyIdInfo': {'id': '24-011159'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Procedure without neuromuscular blockade', 'interventionNames': ['Other: Observation of EMG and AMG readings']}], 'interventions': [{'name': 'Observation of EMG and AMG readings', 'type': 'OTHER', 'description': 'Simultaneous readings from electromyograph and acceleromyograph', 'armGroupLabels': ['Procedure without neuromuscular blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'J. Ross Renew, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'J. Ross Renew, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}