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NCT Number: NCT07133412

An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph

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).

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Key information

Conditions

Surgery

Age range

28 day–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TetraGraph

Device

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.

Primary outcomes

  1. Amplitude

    Time frame: First 30 minutes of surgery

    Average amplitude of the evoked response of the muscles.

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Sponsors and collaborators

Lead sponsor

Joseph D. Tobias

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2025
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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