TetraGraph to Evaluate Onset and Recovery Times of Rocuronium

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nationwide Children's Hospital
Study ID
NCT07435792
Status
Enrolling By Invitation

Conditions

  • Neuromuscular Blockade
  • Surgery

Eligibility Criteria

Sex
ALL
Age
1 Month - N/A
Healthy Volunteers
Not accepted

Interventions

  • TetraGraph — 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

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.

Key Dates

First listed
Feb 27, 2026
Start date
Aug 25, 2026
Status verified
Sep 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Neuromuscular blockade
    Patients receiving a neuromuscular blockade with rocuronium 0.6 mg/kg.

Primary Outcome Measure

Onset time [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205-

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By research site
Nationwide Children's Hospital· Columbus, OH

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