The TOF3D Mechanomyograph. Evaluation of a New Device for Assessment of the Neuromuscular Block.
This study is testing a new device called the TOF3D Mechanomyograph, which measures how much your muscles are relaxed during surgery under general anaesthetic. When you have an operation, doctors often give you medicines to relax your muscles. Currently, they use a different device to check how well these medicines are working. The new device uses a method called mechanomyography, which has mostly been used in research until now. Researchers believe it might be more precise and offer more options for testing muscle relaxation. The study has two main parts: first, it compares the new device directly with the standard device. In the second part, it compares two of these new mechanomyograph devices using different ways of testing.
At a glance
What is this study about?
When you have an operation under general anaesthetic, doctors often give you medicines to make your muscles completely relax. This is really important to ensure you don't move during surgery and that they can safely perform the procedure. To make sure you're getting the right amount of muscle relaxant, neither too much nor too little, doctors need to accurately measure how relaxed your muscles are. Currently, they usually use a device that measures muscle twitches using a method called acceleromyography.
This study is looking at a new device that uses a different method called mechanomyography. This new method has mostly been used in research settings in the past, but scientists believe it could be even more precise than the current standard. It might also offer more different ways to test muscle relaxation, which could give doctors more helpful information during your surgery.
The main aim is to see if this new device is better or as good as the ones currently used. The study will do this in two steps: first, by directly comparing the new device with the standard one. Then, in the second part, they will compare two of the new devices using slightly different ways of testing to see which approach works best.
Key takeaways
- This study evaluates a new device to measure muscle relaxation during surgery.
- It compares a new method (mechanomyography) with the standard method.
- The goal is to find a more precise way to monitor muscle relaxants.
- Participation involves having an extra monitor during your planned surgery.
- The study is for adults aged 18-65 having general anaesthetic and muscle relaxants.
- It aims to improve patient safety and care in the future.
Who may be eligible?
This study is looking for adult patients who are having an operation that requires a general anaesthetic and medicines to relax their muscles. Generally, participants need to be between 18 and 65 years old.
There are some reasons why you might not be able to join the study. For example, if your doctors expect it might be difficult to put a breathing tube in safely, or if there's a higher chance of food or liquid entering your lungs during surgery. You also can't take part if you are pregnant or have certain existing medical conditions that affect your muscles or nerves.
Your medical team can help you understand if this study is right for you, based on your health and the type of surgery you are having.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you aged between 18 and 65?
- Are you having surgery that requires a general anaesthetic?
- Will your surgery involve medicines to relax your muscles?
- Are you not pregnant?
- Do you have no existing muscle or nerve conditions?
- Is your doctor able to easily manage your airway for anaesthesia?
What does participation involve?
If you decide to take part in this study, it would involve having the new TOF3D Mechanomyograph device used during your surgery while you are under general anaesthetic. This would be in addition to the standard monitoring your doctors already use. The device will simply measure your muscle responses, and the study team will collect this information. You won't be given any extra medication for the study itself. There are no extra hospital visits required, and the measurements will only take place during your planned surgery. The total duration of your participation would be limited to the time you are under anaesthetic for your surgical procedure.
Potential risks and benefits
Locations (1)
- Department of Anesthesia and Intensive Care MedicineVerified postcodeBad Hersfeld, Germany· Recruiting
Common questions
What is 'neuromuscular block'?
It's when your muscles are temporarily relaxed, usually with medicine, so you don't move during surgery under general anaesthetic.
What is 'mechanomyography'?
It's a way to measure how your muscles respond to small electrical signals, showing how much they are relaxed.
Will I feel anything different if I participate?
No, you won't feel anything different. The measurements happen while you are asleep under general anaesthetic, and it's a non-invasive process.
Does this study involve new medication?
No, this study is only about testing a new way to measure muscle relaxation; you will receive the standard medications for your surgery.
How long will I be in the study?
Your participation will only last for the duration of your planned surgery while you are under general anaesthetic.
How to find out more
Stefan Soltesz, Professor
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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