TetraGraph in Rocuronium Infusions

April 21, 2026 updated by: Joseph D. Tobias

Train-of-four Monitoring Using the TetraGraph Neuromuscular Transmission Monitor to Evaluate Rocuronium Infusion Requirements During Major Neurosurgical and Surgical Procedures

This is a prospective, non-blinded study to evaluate rocuronium infusion requirements using the TetraGraph Neuromuscular Transmission Monitor during surgical procedures in patients less than 18 yrs. of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients less than 18 years of age
  • American Society of Anesthesiologists classification (ASA) 1-4
  • Patients undergoing a surgical procedure with general anesthesia and requiring the continuous administration of rocuroniuim

Exclusion Criteria:

  • Patients less than 28 days old
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rocuronium infusion
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
Device: TetraGraph
etraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rocuronium Bolus Dose
Time Frame: During the surgery (2-8 hrs.)
Amount of rocuronium administered in a bolus dose during induction of anesthesia.
During the surgery (2-8 hrs.)
Rocuronium Infusion Dose
Time Frame: During surgery (2-8 hrs.)
The amount of rocuronium given by continuous infusion in mg/kg/hr to maintain one twitch of the train of four (TOF)
During surgery (2-8 hrs.)
Maximum Dose of Rocuronium
Time Frame: During the surgery (2-8 hrs.)
The maximum dose of rocuronium administered by a continuous infusion per patient to maintain one twitch of the train of four (TOF)
During the surgery (2-8 hrs.)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rocuronium Infusion Time
Time Frame: During the surgery (2-8 hrs.)
Amount of time in minutes that patients received rocuronium infusion.
During the surgery (2-8 hrs.)
Rocuronium Rescue Boluses
Time Frame: During the surgery (2-8 hrs.)
The number of patient that received rescue boluses of rocuronium in addition to the infusion to maintain one twitch of the train of four (TOF)
During the surgery (2-8 hrs.)
Anesthesia Time
Time Frame: During the surgery (2-8 hrs.)
The total amount of time patients were under anesthesia care in minutes.
During the surgery (2-8 hrs.)
Surgical Time
Time Frame: During the surgery (2-8 hrs.)
The total amount of time from first incision to closure in minutes.
During the surgery (2-8 hrs.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph D. Tobias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2024

Primary Completion (Actual)

April 24, 2025

Study Completion (Actual)

April 24, 2025

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00004154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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