TetraGraph for Neuromuscular Blockade

JR
CR
Overseen ByCatherine Roth, MPH
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Nationwide Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JT

Joseph Tobias, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for patients aged 18 or older who are having surgery with general anesthesia and need the muscle relaxant rocuronium. Participants must be in reasonably stable health (ASA status 1-4) and able to give consent.

Inclusion Criteria

Consenting American Society of Anesthesiologists (ASA) Physical Status 1-4 patients
I am having surgery with general anesthesia and will receive rocuronium.

Exclusion Criteria

My surgery does not require muscle relaxants.
Edematous patients
I have a history of a worsening nerve disorder.

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing the TetraGraph monitor, which measures how quickly and completely muscles become relaxed after giving rocuronium during surgery, as well as how long it takes for muscle function to return.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Neuromuscular blockadeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials
354
Recruited
5,228,000+