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Enrolling by invitationNCT07435792Updated Sep 9, 2026

TetraGraph to Evaluate Onset and Recovery Times of Rocuronium

An interventional study of TetraGraph in Surgery and Neuromuscular Blockade, sponsored by Nationwide Children's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 1 Month and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
1 Month and older
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery
  • Neuromuscular Blockade
03

Who can participate

Ages eligible
1 Month and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Neuromuscular blockade

    Patients receiving a neuromuscular blockade with rocuronium 0.6 mg/kg.

    Device: TetraGraph

Interventions

  • DeviceTetraGraph

    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).

05

What researchers measure

Primary outcomes

  1. Onset time

    Amount of time from administration of rocuronium to the monitor reading 0 twitches.

    Time frame: Baseline

Secondary outcomes

  1. Recovery time

    Amount of time from administration of reversal medication (sugammadex or neostigmine) to monitor reading 4 twitches.

    Time frame: At the completion of surgery

06

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07435792
Lead sponsor
Nationwide Children's Hospital
Responsible party
Joseph D. Tobias (Chief - Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital) — Principal investigator
First posted
Feb 27, 2026
Start date
Aug 25, 2026
Primary completion
May 31, 2029 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Sep 9, 2026

Study contacts

Joseph Tobias, MD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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