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Completed

NCT Number: NCT04475250

Train-of-four Monitoring Using the Tetragraph

This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.

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Key information

Conditions

Surgery

Age range

2 year–18 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

  • Pediatric patients requiring anesthetic care and use of neuromuscular blockade
  • Weight range of 20 - 60 kg

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 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. Baseline TOFr (%)

    Time frame: Immediately prior to start of surgery

    Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis.

  2. Recovered TOFr (%)

    Time frame: At the end of surgery (maximum 7 hours from baseline)

    Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block.

Secondary outcomes

  1. Baseline Amplitude (mV)

    Time frame: Immediately prior to start of surgery

    The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent.

  2. Recovered Amplitude (mV)

    Time frame: At the end of surgery (maximum 7 hours from baseline)

    The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent.

  3. Rate of Muscle Recovery (Minutes)

    Time frame: At the end of surgery (maximum 7 hours from baseline)

    The amount of time it took to return to a TOFr >90% following reversal of neuromuscular blocking agent.

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2020
Registry last updated
Aug 12, 2024

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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