Train-of-four Monitoring Using the Tetragraph

Joseph D. Tobias100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Surgery

Interventions

Tetragraph (TM) NMT MonitorDEVICE

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Baseline TOFr (%)

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.

Time frame: Immediately prior to start of surgery

Recovered TOFr (%)

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.

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

Secondary Outcomes

Baseline Amplitude (mV)

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

Time frame: Immediately prior to start of surgery

Recovered Amplitude (mV)

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

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

Rate of Muscle Recovery (Minutes)

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

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

Data from ClinicalTrials.gov

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