eurostimulation and Electromyographic Assessment of the TetraGraph

Completed

• Conditions: algehele anesthesie met spierverslappers; anesthetized and neuromuscular blockade

• Registration Number: NL-OMON40867
• Lead Sponsor: Anesthesiologie - Onderzoeksbureau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 18 years or older;
- Subject meets the American Society of Anesthesiology (ASA) physical status
I-III criteria (Table I);
- Subject has provided written informed consent.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- - Presence of an underlying neuromuscular disease
- Presence of renal or hepatic disease
- Subject has open skin sores at locations needed for electrode application
- Patient is taking the following medication:
- anti-seizure medication
- anti-cholinestase medication
- magnesium sulfate

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to provide safety and performance data<br /><br>of the TetraGraph device on anesthetized subjects. Performance will be assessed<br /><br>post hoc by analyzing objective EMG data and correlating with the responses to<br /><br>annotations made during the surgical procedure (e.g., correlating the EMG<br /><br>responses to the time of NMBA administration)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Investigating the quality of the applied skin electrodes (clinically<br /><br>available 3M Red Dot electrodes)<br /><br>- Observing the applicability of the prototype (easy of use, *)</p><br>