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Completed

NCT Number: NCT06472284

TetraGraph in Rocuronium Infusions

This is a prospective, non-blinded study to evaluate rocuronium infusion requirements using the TetraGraph Neuromuscular Transmission Monitor during surgical procedures in patients less than 18 yrs. of age.

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Key information

Conditions

Surgery

Age range

28 day–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

  • Patients less than 18 years of age
  • American Society of Anesthesiologists classification (ASA) 1-4
  • Patients undergoing a surgical procedure with general anesthesia and requiring the continuous administration of rocuroniuim

Exclusion criteria

  • Patients less than 28 days old
  • Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
  • Patients undergoing a surgical procedure in which neuromuscular blockade is not required
  • Edematous patients

Treatment and study plan

TetraGraph

Device

etraGraph 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. Rocuronium Bolus Dose

    Time frame: During the surgery (2-8 hrs.)

    Amount of rocuronium administered in a bolus dose during induction of anesthesia.

  2. Rocuronium Infusion Dose

    Time frame: During surgery (2-8 hrs.)

    The amount of rocuronium given by continuous infusion in mg/kg/hr to maintain one twitch of the train of four (TOF)

  3. Maximum Dose of Rocuronium

    Time frame: During the surgery (2-8 hrs.)

    The maximum dose of rocuronium administered by a continuous infusion per patient to maintain one twitch of the train of four (TOF)

Secondary outcomes

  1. Rocuronium Infusion Time

    Time frame: During the surgery (2-8 hrs.)

    Amount of time in minutes that patients received rocuronium infusion.

  2. Rocuronium Rescue Boluses

    Time frame: During the surgery (2-8 hrs.)

    The number of patient that received rescue boluses of rocuronium in addition to the infusion to maintain one twitch of the train of four (TOF)

  3. Anesthesia Time

    Time frame: During the surgery (2-8 hrs.)

    The total amount of time patients were under anesthesia care in minutes.

  4. Surgical Time

    Time frame: During the surgery (2-8 hrs.)

    The total amount of time from first incision to closure in minutes.

Sponsors and collaborators

Lead sponsor

Joseph D. Tobias

Other

Registry information

Official study title

Train-of-four Monitoring Using the TetraGraph Neuromuscular Transmission Monitor to Evaluate Rocuronium Infusion Requirements During Major Neurosurgical and Surgical Procedures

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 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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