- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07371377
The TOF3D Mechanomyograph. Evaluation of a New Device for Assessment of the Neuromuscular Block. (MMG versus AMG)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefan Soltesz, Professor
- Phone Number: 0049 6621 88 922775
- Email: stefan.soltesz@klinikum-hef.de
Study Locations
-
-
-
Bad Hersfeld, Germany, 36251
- Recruiting
- Department of Anesthesia and Intensive Care Medicine
-
Contact:
- Stefan Soltesz, Professor
- Phone Number: 0049 173 3262086
- Email: stefan.soltesz@klinikum-hef.de
-
Principal Investigator:
- Stefan Soltesz, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: comparison of mechanomyograph and acceleromyograph
|
a new device is compared to an established one.
|
|
Other: comparison of tetanic fade versus train of four ratio
|
a new device is compared to an established one.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MMG and TOF3D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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