Neurostimulation and Electromyographic Assessment of the TetraGraph (NEAT) In Patients (NEAT-3)

University of Debrecen

Status: Completed

Conditions: Neuromuscular Blockade

Study type: Observational

Funder types: Other

Identifiers

NCT02241304

ADBV-ABS-0214-NEAT-3H

DE RKEB/IKEB 4170-2014 (Registry Identifier)

028605/2014/OTIG (Registry Identifier)

Details and patient eligibility

About

TetraGraph is a newly developed EMG-based, quantitative, battery-powered neuromuscular monitoring system intended for daily clinical use. The primary aim of this clinical investigation is to examine the applicability (ease of use, equipment need, etc.), repeatability (precision or internal consistency) and performance (signal quality, accuracy of outcome, voltage of stimulation output before and during a stimulus) of the Tetragraph device in patients undergoing elective surgeries requiring neuromuscular blockade.

Full description

The TetraGraph will be tested in 50 consenting patients undergiong elective surgeries requiring neuromuscular blockade. The left of right hand of the patients will be randomly studied. After the induction of anesthesia but before the administration of muscle relaxant train-of-four (TOF) stimulation will be started with 30 mA current intensity, 0.2 msec pulse duration at 20 sec intervals. The stimulation will be left to run until extubation. The TetraGraph device will be set not to show measurement results on the screen but save them on the SD card for later analysis. This way TetraGraph will not influence clinical decisions and patient care. During the operations we will record the number of muscle twitches in return to stimulation, the time and dose of muscle relaxant and opioid administration, the time of use of electrocautery and the skin temperature.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older.
2. American Society of Anesthesiology (ASA) physical status I-III criteria (Table I).
3. Subject has provided written informed consent.

Exclusion criteria

1. Presence of an underlying neuromuscular disease.
2. Presence of renal or hepatic disease.
3. Subject has open skin sores in the locations needed for electrode application (forearms).
4. Patient is taking anti-seizure medication
5. Patient is taking oral anti-cholinesterase (e.g., therapy for myasthenia gravis)
6. Magnesium sulfate administration is required

Trial design

50 participants in 1 patient group

Elective surgery with muscle relaxation

Description:

ASA I-II-III patients. Fentanyl (2-3 ug/kg) - Propofol (2 mg/kg) induction, sevoflurane anesthesia, type and dose of muscle relaxant up to the decision of attending anesthetist. Neuromuscular stimulation with TetraGraph (30mA current intensity, 0.2 msce pulse duration, 20 sec intervals)