NCT06472284

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

June 19, 2024

Last Update Submit

January 27, 2026

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

  • EMG changes

    Changes in the amplitude of the evoked response of the muscles

    During the surgery (2-8 hrs.)

  • Maximum dose of rocuronium

    The maximum dose of rocuronium administered by a continuous infusion to maintain one twitch of the train of four (TOF)

    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

TetraGraphDEVICE

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

Age28 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

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

February 1, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(1)