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

NCT04931901 | Completed

• 1 other identifier: StimpodVSDatex-Ohmeda
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Manifestations

Outcome Measures

Primary Outcomes (1)

• TOF-ratio (percentage)

  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

  Up until 120 minutes

Secondary Outcomes (1)

• TOF-count (absolute number)

  Up until 120 minutes.

Study Arms (2)

Stimpod NMX450X

EXPERIMENTAL

Device: EMG TOF device

Datex-Ohmeda E-NMT

ACTIVE COMPARATOR

Device: EMG TOF device

Interventions

EMG TOF device DEVICE

Use of Stimpod NMX450X as an electromyographic neuromuscular monitor

Datex-Ohmeda E-NMT; Stimpod NMX450X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Neuromuscular Manifestations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 18, 2021
• Study Start: September 6, 2021
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)