Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:19 PM
Study NCT ID:
NCT07435792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TetraGraph to Evaluate Onset and Recovery Times of Rocuronium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-21', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset time', 'timeFrame': 'Baseline', 'description': 'Amount of time from administration of rocuronium to the monitor reading 0 twitches.'}], 'secondaryOutcomes': [{'measure': 'Recovery time', 'timeFrame': 'At the completion of surgery', 'description': 'Amount of time from administration of reversal medication (sugammadex or neostigmine) to monitor reading 4 twitches.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': 'In most clinical instances, direct laryngoscopy and endotracheal intubation is performed after a set time (generally 60 seconds) following the administration of a neuromuscular (NM) blocking agent, rocuronium. Although the average onset time is 60 seconds, clinical studies show a standard deviation around the mean onset time of 10-20 seconds, meaning that a significant number of patients do not achieve complete NM blockade by 60 seconds. Given the above noted variability, complete NM blockade may not be achieved in 60 seconds in a significant percentage of patients, resulting in more problematic direct laryngoscopy and endotracheal intubation. Various studies have shown a higher incidence of perioperative respiratory events and postoperative concerns (sore throat, vocal cord injury) when NM blockade is not complete prior to endotracheal intubation.\n\nThis study aims to use the TetraGraph monitor to clearly identify onset times of rocuronium. Additionally, whenever feasible based on the clinical needs of the case, recovery times after the single dose of rocuronium will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consenting American Society of Anesthesiologists (ASA) Physical Status 1-4 patients\n* undergoing a surgical procedure with general anesthesia and requiring the administration of rocuronium\n\nExclusion Criteria:\n\n* Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder\n* Patients undergoing a surgical procedure in which neuromuscular blockade is not required\n* Edematous patients'}, 'identificationModule': {'nctId': 'NCT07435792', 'briefTitle': 'TetraGraph to Evaluate Onset and Recovery Times of Rocuronium', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Train-of-four Monitoring Using the TetraGraph Electromyographic Neuromuscular Transmission Monitor to Evaluate Onset and Recovery Times of a Single Bolus Dose of Rocuronium', 'orgStudyIdInfo': {'id': 'STUDY00005738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neuromuscular blockade', 'description': 'Patients receiving a neuromuscular blockade with rocuronium 0.6 mg/kg.', 'interventionNames': ['Device: TetraGraph']}], 'interventions': [{'name': 'TetraGraph', 'type': 'DEVICE', 'description': 'A monitor that provides an electrical stimulation of the peripheral nerve and directly measures the amplitude of the evoked response of the muscles, thereby providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG).', 'armGroupLabels': ['Neuromuscular blockade']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julie Rice-Weimer, BSN', 'role': 'CONTACT', 'email': 'julie.rice-weimer@nationwidechildrens.org', 'phone': '614-355-3142'}, {'name': 'Catherine Roth, MPH', 'role': 'CONTACT', 'email': 'catherine.roth@nationwidechildrens.org'}], 'overallOfficials': [{'name': 'Joseph Tobias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief - Department of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}