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An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph

An Evaluation of the Neuromuscular Junction in Infants Using Train-of-four Monitoring With the TetraGraph™ Neuromuscular Transmission Monitor

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07133412
Enrollment
100
Registered
2025-08-21
Start date
2026-07-01
Completion date
2027-12-01
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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).

Interventions

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.

Sponsors

Joseph D. Tobias
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
28 Days to 25 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
AmplitudeFirst 30 minutes of surgeryAverage amplitude of the evoked response of the muscles.

Countries

United States

Contacts

CONTACTJulie Rice-Weimer, RN
julie.rice-weimer@nationwidechildrens.org614-355-3142
CONTACTCatherine Roth, MPH
catherine.roth@nationwidechildrens.org614-722-2997
PRINCIPAL_INVESTIGATORJoseph D Tobias, MD

Nationwide Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026