Paired Assessment of Two Electromyographic Neuromuscular Monitors: Stimpod NMX450X Versus Datex-Ohmeda E-NMT

Not Applicable

Recruiting

• Conditions: Neuromuscular Manifestations
• Interventions: Device: EMG TOF device

• Registration Number: NCT04931901
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

After anesthesia is induced, 2 EMG TOFF devices will be placed on the patients arms, one on the right arm, the other on the left. There will be a randomization per dominant hand and nondominant hand for the placing of the devices. The devices are the Stimpod NMX450X and the Datex-Ohmeda E-NMT.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-18
• Study Start: 2021-09-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult patients (18 years old and above)
• undergoing General Anaesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent.

Exclusion Criteria

• Use of different types of neuromuscular blocking agents for the same patient within the same surgical procedure.
• Known Neuromuscular diseases/syndromes judged to condition accurate neuromuscular monitoring.
• Known acute or chronic hepatic disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stimpod NMX450X	EMG TOF device	-
Datex-Ohmeda E-NMT	EMG TOF device	-

Primary Outcome Measures

Name	Time	Method
TOF-ratio (percentage)	Up until 120 minutes	TOF = Train-of-four. TOF-ratio is the ratio of the fourth muscle response to the first one. This is used to assess neuromuscular transmission. TOF% indicates fade in non-depolarizing block. We are comparing the calculated TOF ratio of the stimpod NMX to the datex-ohmeda E-NMT

Secondary Outcome Measures

Name	Time	Method
TOF-count (absolute number)	Up until 120 minutes.	TOF count is the actual number of detected muscle responses. The number that is used to calculate the percentage (TOF-ratio). When the TOF count drops below 4 responses, then the TOF% cannot be calculated. We are comparing the detected muscle responses of the stimpod NMX to the datex-ohmeda E-NMT

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussel, Belgium