TetraGraph to Evaluate Onset and Recovery Times of Rocuronium

Train-of-four Monitoring Using the TetraGraph Electromyographic Neuromuscular Transmission Monitor to Evaluate Onset and Recovery Times of a Single Bolus Dose 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Neuromuscular Blockade
• Intervention / Treatment: Device: TetraGraph

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Rice-Weimer, BSN; Phone Number: 614-355-3142; Email: Julie.Rice-Weimer@nationwidechildrens.org
• Study Contact Backup: Name: Catherine Roth, MPH; Email: Catherine.Roth@nationwidechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromuscular blockade; Patients receiving a neuromuscular blockade with rocuronium 0.6 mg/kg.	Device: TetraGraph; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset time	Amount of time from administration of rocuronium to the monitor reading 0 twitches.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	Amount of time from administration of reversal medication (sugammadex or neostigmine) to monitor reading 4 twitches.	At the completion of surgery

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Investigators: Principal Investigator: Joseph Tobias, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: February 21, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00005738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No