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

NCT ID: NCT04931901

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Neuromuscular Manifestations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization per dominant and nondominant hand. So that there is an even share of number of patients with Stimpod NMX450X on dominant hand and Datex-Ohmeda E-NMT.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Stimpod NMX450X

Group Type EXPERIMENTAL

EMG TOF device

Intervention Type DEVICE

Use of Stimpod NMX450X as an electromyographic neuromuscular monitor

Datex-Ohmeda E-NMT

Group Type ACTIVE_COMPARATOR

EMG TOF device

Intervention Type DEVICE

Use of Stimpod NMX450X as an electromyographic neuromuscular monitor

Interventions

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EMG TOF device

Use of Stimpod NMX450X as an electromyographic neuromuscular monitor

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Evelien Vandeurzen, MSC

Role: CONTACT

024749237

Facility Contacts

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Evelien Vandeurzen, Biomedical Sciences

Role: primary

024749237

Other Identifiers

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StimpodVSDatex-Ohmeda

Identifier Type: -

Identifier Source: org_study_id

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