What this study is
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.
What's being tested
- TetraGraph
Intervention · DEVICE
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).
Study details
- Official title
- Train-of-four Monitoring Using the TetraGraph Electromyographic Neuromuscular Transmission Monitor to Evaluate Onset and Recovery Times of a Single Bolus Dose of Rocuronium
- Sponsor
- Nationwide Children's Hospital
- Conditions
- Surgery · Neuromuscular Blockade
- Enrolling
- 130 people
- Starts
- 2026-08-25
- Est. completion
- 2029-05-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Month and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Consenting American Society of Anesthesiologists (ASA) Physical Status 1-4 patients
- Undergoing a surgical procedure with general anesthesia and requiring the administration of rocuronium
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNationwide Children's Hospital
Columbus, Ohio, United States
Study team
Sponsor
Nationwide Children's Hospital
Study ID STUDY00005738
Principal investigator
Joseph Tobias, MD
Nationwide Children's Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.