NCT07371377

Brief Summary

In clinical anesthesiologic practice, most institutions use acceleromyography in order to assess the degree of a neuromuscular block. The aim of the present study is to assess a new device using mechanomyography. Until recently, this method was reserved for experimental settings. It seems to be able to work more precisely, and additionally, it offers the opportunity to use other stimulation patterns than acceleromyographic measurements. The investigation is divided into two parts: Part 1 compares the mechanomyograph directly with an acceleromyograph. In part 2, two mechanomyographs using different stimulation patterns are compared with each other.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Jan 2026Jul 2027

Study Start

First participant enrolled

January 9, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 10, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 10, 2026

Last Update Submit

January 19, 2026

Conditions

MechanomyographyNeuromuscular Blockade Monitoring

Keywords

mechanomyographytetanic fade

Outcome Measures

Primary Outcomes (1)

  • difference in time to recovery to a train of four ratio of 1,0.

    difference in time to recovery to a train of four ratio of 1,0 measured by acceleromyography and mechanomyography, respectively

    from enrollment to the end of anesthesiologic treatment at the day of surgery (2-3 weeks after enrollment)

Study Arms (2)

comparison of mechanomyograph and acceleromyograph

OTHER
Device: measurement of the time course of a neuromuscular block

comparison of tetanic fade versus train of four ratio

OTHER
Device: measurement of the time course of a neuromuscular block

Interventions

measurement of the time course of a neuromuscular blockDEVICE

a new device is compared to an established one.

comparison of mechanomyograph and acceleromyographcomparison of tetanic fade versus train of four ratio

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for surgery requiring general anesthesia with neuromuscular blocking agents

You may not qualify if:

  • anticipated or known difficult airway
  • increased risk for aspiration
  • pregnancy
  • neuromuscular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia and Intensive Care Medicine

Bad Hersfeld, 36251, Germany

RECRUITING

Central Study Contacts

Stefan Soltesz, Professor

CONTACT

0049 6621 88 922775stefan.soltesz@klinikum-hef.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2026

First Posted

January 27, 2026

Study Start

January 9, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)