The TOF3D Mechanomyograph. Evaluation of a New Device for Assessment of the Neuromuscular Block.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKlinikum Hersfeld-Rotenburg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients scheduled for surgery requiring general anesthesia with neuromuscular blocking agents
Disqualifiers
anticipated or known difficult airway
increased risk for aspiration
pregnancy
neuromuscular disorders
Trial design
Design model
Parallel
Treatments tested in this trial
measurement of the time course of a neuromuscular block
Devicea new device is compared to an established one.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: comparison of mechanomyograph and acceleromyographOther 1 intervention
Group B: comparison of tetanic fade versus train of four ratioOther 1 intervention
Trial outcomes
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
Time frame
from enrollment to the end of anesthesiologic treatment at the day of surgery (2-3 weeks after enrollment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov