The TOF3D Mechanomyograph. Evaluation of a New Device for Assessment of the Neuromuscular Block.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: measurement of the time course of a neuromuscular block.
- Who it may be relevant to
- Registry conditions: Mechanomyography, Neuromuscular Blockade Monitoring. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device measurement of the time course of a neuromuscular block
a new device is compared to an established one.
Primary outcome measures
- difference in time to recovery to a train of four ratio of 1,0. [Time frame: from enrollment to the end of anesthesiologic treatment at the day of surgery (2-3 weeks after enrollment)]
Eligibility criteria
Inclusion criteria
- patients scheduled for surgery requiring general anesthesia with neuromuscular blocking agents
Exclusion criteria
- anticipated or known difficult airway
- increased risk for aspiration
- pregnancy
- neuromuscular disorders
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Germany · 1 center
- Department of Anesthesia and Intensive Care Medicine — Bad Hersfeld
Identifiers
NCT: NCT07371377 · MMG and TOF3D