CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
TetraGraph (TG) +1 moredevice
Likely dose
Not stated in record
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Search/NCT03920670
NCT03920670N/ACompleted
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Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

Mayo Clinic·interventional·Posted Apr 19, 2019·Updated Apr 29, 2021

In Brief

A clinical study evaluating TetraGraph (TG) and ToFscan (TS) for Residual Neuromuscular Blockade. Completed, enrolled 120 participants across 3 sites in 2 countries.

Detailed Summary

The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsResidual Neuromuscular Blockade
CountriesHungary, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 19, 2019
Enrollment StartFeb 28, 2019
Primary CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.2 years ago

Interventions

TetraGraph (TG)device

TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.

ToFscan (TS)device

ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.