TetraGraph in Rocuronium Infusions

NCT06472284 | Completed Results FDA Device

• 1 other identifier: STUDY00004154
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (3)

• Rocuronium Bolus Dose

  Amount of rocuronium administered in a bolus dose during induction of anesthesia.

  During the surgery (2-8 hrs.)

• Rocuronium Infusion Dose

  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

  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 Outcomes (4)

• Rocuronium Infusion Time

  During the surgery (2-8 hrs.)

• Rocuronium Rescue Boluses

  During the surgery (2-8 hrs.)

• Anesthesia Time

  During the surgery (2-8 hrs.)

• Surgical Time

  During the surgery (2-8 hrs.)

Study Arms (1)

Rocuronium infusion

EXPERIMENTAL

Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.

Device: TetraGraph

Interventions

TetraGraph DEVICE

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.

Rocuronium infusion

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph D. Tobias: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Results Point of Contact

• Title: Dr. Joseph Tobias
• Organization: Nationwide Children's Hospital

Joseph.Tobias@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: September 12, 2024
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: May 13, 2026
• Results First Posted: May 13, 2026

Record last verified: 2026-01

Locations

US (1)