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TetraGraph to Evaluate Onset and Recovery Times of Rocuronium

Train-of-four Monitoring Using the TetraGraph Electromyographic Neuromuscular Transmission Monitor to Evaluate Onset and Recovery Times of a Single Bolus Dose of Rocuronium

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07435792
Enrollment
130
Registered
2026-02-27
Start date
2026-06-01
Completion date
2029-05-31
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade, Surgery

Brief summary

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. This 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.

Interventions

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).

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* consenting American Society of Anesthesiologists (ASA) Physical Status 1-4 patients * undergoing a surgical procedure with general anesthesia and requiring the administration of rocuronium

Exclusion criteria

* Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder * Patients undergoing a surgical procedure in which neuromuscular blockade is not required * Edematous patients

Design outcomes

Primary

MeasureTime frameDescription
Onset timeBaselineAmount of time from administration of rocuronium to the monitor reading 0 twitches.

Secondary

MeasureTime frameDescription
Recovery timeAt the completion of surgeryAmount of time from administration of reversal medication (sugammadex or neostigmine) to monitor reading 4 twitches.

Contacts

CONTACTJulie Rice-Weimer, BSN
julie.rice-weimer@nationwidechildrens.org614-355-3142
CONTACTCatherine Roth, MPH
catherine.roth@nationwidechildrens.org
PRINCIPAL_INVESTIGATORJoseph Tobias, MD

Nationwide Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026