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Not Yet RecruitingNCT07435792

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
Phase
N/A
Study type
Interventional
Enrollment
130 (estimated)
Sponsor
Nationwide Children's Hospital · Academic / Other
Sex
All
Age
1 Month
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICETetraGraphA 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).

Timeline

Start date
2026-06-01
Primary completion
2029-05-31
Completion
2029-05-31
First posted
2026-02-27
Last updated
2026-02-27

Source: ClinicalTrials.gov record NCT07435792. Inclusion in this directory is not an endorsement.