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

Primary Purpose

Neuromuscular Manifestations

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

EMG TOF device

About this trial

This is an interventional supportive care trial for Neuromuscular Manifestations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stimpod NMX450X

Datex-Ohmeda E-NMT

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04931901

First Posted

June 8, 2021

Last Updated

November 2, 2022

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT04931901

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 6, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuromuscular Manifestations

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stimpod NMX450X

Arm Type

Experimental

Arm Title

Datex-Ohmeda E-NMT

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

EMG TOF device

Intervention Description

Use of Stimpod NMX450X as an electromyographic neuromuscular monitor

Primary Outcome Measure Information:

Title

TOF-ratio (percentage)

Description

Time Frame

Up until 120 minutes

Secondary Outcome Measure Information:

Title

TOF-count (absolute number)

Description

Time Frame

Up until 120 minutes.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evelien Vandeurzen, MSC

Phone

024749237

evelien.vandeurzen@uzbrussel.be

Facility Information:

Facility Name

UZ Brussel

City

Jette

State/Province

Brussel

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Contact: