Skip to main content
OpenTrials
Completed

NCT Number: NCT03360825

Electrophysiological Comparison of mAP and mADM Using EMG

The primary aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

This is a blinded, single-center, prospective study in patients during surgery, requiring use of neuromuscular blockade. Neurostimulation will be used to monitor objective responses, as per current clinical routine. Data collection of Tetragraph EMG responses will be unavailable to the clinician for clinical decision-making, as per current clinical routine, but will be stored on the interfaced SD card.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older.
  • American Society of Anesthesiology (ASA) physical status I-III criteria (Table I).
  • Subject has provided verbal consent
  • BMI <39

Exclusion criteria

  • Presence of an underlying neuromuscular disease.
  • Presence of renal or hepatic disease.
  • Subject has open skin sores in the locations needed for electrode application (forearms).
  • Patients on oral anticholinesterase, anti-seizure medications, and magnesium sulfate.

Treatment and study plan

TetraGraph

Device

The TetraGraph is a dedicated neuromuscular stimulator / recorder intended to evoke, record, and analyze muscle action potentials during surgical procedures

Primary outcomes

  1. Primary performance assessment of TetraGraph device

    Time frame: Duration of surgery

    Agreement between the mAP and mADM EMG based TOF ratios

  2. Primary performance assessment of TetraGraph device

    Time frame: Duration of surgery

    Agreement between the mAP and mADM EMG based TOF counts

Secondary outcomes

  1. Secondary performance assessment of TetraGraph device

    Time frame: Duration of surgery

    Correlation between stimulation current and T1 twitch height in the two muscles

  2. Secondary performance assessment of TetraGraph device

    Time frame: Duration of surgery

    Comparison of EMG to the quantitative AMG monitor

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2017
Registry last updated
Mar 7, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.