NCT07133412

Brief Summary

The goal of this study is to use electromyography-based train-of-four monitoring (TetraGraph™ Neuromuscular Transmission Monitor) as a means of evaluating differences in neuromuscular transmission between infants ≤ 3 months of age and adolescent and older patients (≥ 12 years of age).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
19mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress18%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

August 19, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

August 19, 2025

Last Update Submit

October 24, 2025

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Amplitude

    Average amplitude of the evoked response of the muscles.

    First 30 minutes of surgery

Study Arms (2)

Infants

EXPERIMENTAL

Infants 28 days to 3 months old undergoing surgery.

Device: TetraGraph

Adolescents

ACTIVE COMPARATOR

Adolescents/young adults 12 years of age or above undergoing surgery.

Device: TetraGraph

Interventions

TetraGraphDEVICE

TetraGraph 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.

AdolescentsInfants

Eligibility Criteria

Age28 Days - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA 1-3 patients
  • Aged 28 days - 3 months or ≥ 12 years
  • Undergoing a surgical procedure with a volatile-agent based anesthetic that does not require administration of a neuromuscular blocking agent

You may not qualify if:

  • Patients with history of a peripheral neurologic or neuropathic disorder
  • Patients in whom the upper extremity cannot be used for TOF monitoring
  • Patients undergoing a surgical procedure in which neuromuscular blockade is required
  • Edematous patients
  • Patients receiving total intravenous anesthesia (TIVA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

  • Joseph D Tobias, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Rice-Weimer, RN

CONTACT

614-355-3142julie.rice-weimer@nationwidechildrens.org

Catherine Roth, MPH

CONTACT

614-722-2997catherine.roth@nationwidechildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief - Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 21, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 27, 2025

Record last verified: 2025-10

Locations

US(1)