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Completed

NCT Number: NCT06458023

TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age

The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age.

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Key information

Conditions

Surgery

Age range

1 month–12 month

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 1-4
  • ≤ 1 year of age
  • undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA

Exclusion criteria

  • Patients less than 28 days old
  • 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 not required
  • Edematous patients

Treatment and study plan

TetraGraph (TM) NMT Monitor

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. TOFr (%)

    Time frame: During the surgery (1-3 hrs. avg.)

    The Train of Four ratio (TOFr) is a quantitative measure used in anesthesia to assess the depth of neuromuscular blockade and recovery, calculated by dividing the amplitude of the fourth twitch by the first twitch after four 2-Hz stimuli. A TOF ratio is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents. A TOF ratio >/= 90% is the standard threshold for safe extubation and indicates sufficient recovery from nondepolarizing agents.

  2. Amplitude

    Time frame: During the surgery (1-3 hrs. avg.)

    The amplitude of the muscle action potential in response to electrical stimulation of its corresponding peripheral nerve.

Secondary outcomes

  1. Rate of Muscle Recovery

    Time frame: Baseline, After reversal of neuromuscular blockade during surgery (avg of 1-3 hrs)

    The amount of time from administration of neuromuscular blockade reversal agent to muscle recovery (TOFr >/= 90).

Sponsors and collaborators

Lead sponsor

Joseph D. Tobias

Other

Registry information

Official study title

Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator in Patients Less Than 1 Year of Age.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
May 13, 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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