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

Neuromuscular Manifestations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931901
• Other study ID #: StimpodVSDatex-Ohmeda
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Universitair Ziekenhuis Brussel
• Contact: Evelien Vandeurzen, MSC
• Phone: 024749237
• Email: evelien.vandeurzen[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuromuscular Manifestations

Intervention

Device:
• EMG TOF device
Use of Stimpod NMX450X as an electromyographic neuromuscular monitor

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.