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NCT Number: NCT07435792

TetraGraph to Evaluate Onset and Recovery Times of Rocuronium

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.

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Key information

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Onset time

    Time frame: Baseline

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

Secondary outcomes

  1. Recovery time

    Time frame: At the completion of surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Roth, MPH

CONTACT

[email protected]

Julie Rice-Weimer, BSN

CONTACT

[email protected]

614-355-3142

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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