TetraGraph to Evaluate Onset and Recovery Times of Rocuronium

NCT07435792 | Enrolling By Invitation

• 1 other identifier: STUDY00005738
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Surgery; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Onset time

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

  Baseline

Secondary Outcomes (1)

• Recovery time

  At the completion of surgery

Study Arms (1)

Neuromuscular blockade

EXPERIMENTAL

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

Device: TetraGraph

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).

Neuromuscular blockade

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• consenting American Society of Anesthesiologists (ASA) Physical Status 1-4 patients
• undergoing a surgical procedure with general anesthesia and requiring the administration of rocuronium

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

• Joseph Tobias, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief - Department of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)