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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Manifestations
• Intervention / Treatment: Device: EMG TOF device

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evelien Vandeurzen, MsC; Phone Number: 024749237; Email: evelien.vandeurzen@uzbrussel.be

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Recruiting
      • UZ Brussel
      • Contact: Evelien Vandeurzen, Biomedical Sciences; Phone Number: 024749237; Email: evelien.vandeurzen@uzbrussel.be
      • Principal Investigator: Hugo Carvalho, MD
      • Sub-Investigator: Panagiotis Flamée, MD
      • Sub-Investigator: Michael Verdonck, MD
      • Sub-Investigator: Gregory Van Stighel, MD
      • Sub-Investigator: Philippe Kinnaer, MD
      • Sub-Investigator: William Alliet, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimpod NMX450X	Device: EMG TOF device; Use of Stimpod NMX450X as an electromyographic neuromuscular monitor
Active Comparator: Datex-Ohmeda E-NMT	Device: EMG TOF device; Use of Stimpod NMX450X as an electromyographic neuromuscular monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
TOF-count (absolute number)	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	Up until 120 minutes.

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations
• Other Study ID Numbers: StimpodVSDatex-Ohmeda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No