Active not recruitingOBSERVATIONAL

Does Electromyography Improve Precision and Reliability of Neuromuscular Monitoring in Paediatric Patients

This study, called ETCETERA, is comparing two different ways of checking muscle recovery in young children (under 5 years old) during surgery. When children have an operation, doctors sometimes give medicines to relax their muscles. To make sure these muscles fully recover afterwards, doctors use special monitors. Current monitoring devices work well for adults but aren't always as accurate for children because children's bodies are different. The study will look at two technologies: Electromyography (EMG) and Kinemyography (KMG). Researchers want to find out if one method is more accurate and reliable than the other in young children. The goal is to improve how doctors monitor children, helping to prevent problems after surgery and ensure a safer recovery.

At a glance

Status

Active not recruiting

Sponsor

University Hospital Ulm

Enrolment target

Start

20 Sep 2023

Estimated completion

10 Dec 2024

Neuromuscular Blockade, Residual Postoperative Complications

What is this study about?

When children have an operation, they often receive a general anaesthetic which can include medicines to relax their muscles. This muscle relaxation helps the surgeons do their work more easily. However, it's really important that these muscles are fully recovered and working properly again by the time the anaesthetic wears off.

At the moment, doctors use special devices to keep an eye on how well a child's muscles are recovering. While these devices work very well for adults, they can sometimes be less precise in babies and young children. This is because tiny bodies are different from adult bodies in many ways, including how they react to medicines. Because of these differences, there's a need for better ways to monitor muscle function in our youngest patients.

This study, called ETCETERA, aims to find out if newer monitoring devices using a technology called Electromyography (EMG) are more accurate and reliable than the older Kinemyography (KMG) devices for children under 5 years old. This research is crucial because having more accurate monitoring can help doctors make sure children are fully recovered from muscle relaxants, which helps avoid issues like breathing difficulties after surgery and makes their recovery smoother and safer.

Key takeaways

The study helps doctors find better ways to monitor children's muscle recovery during surgery.
It compares two monitoring methods: EMG (electrical signals) and KMG (muscle movement).
Participation is for children under 5 having certain types of surgery.
The monitoring is part of routine surgical care; no extra procedures.
The goal is safer anaesthesia and smoother recovery for young patients.

Who may be eligible?

This study is looking for babies and children who are under 5 years old and are scheduled to have a non-heart operation where they will be given a general anaesthetic and medicines to relax their muscles. You and your child's doctors would need to agree for your child to take part, and your child should be generally healthy, as rated by their doctors.

There are some reasons why a child might not be able to join the study. For example, if they have allergies to the muscle-relaxing medicines or to the sticky pads used for monitoring. Children with certain nerve or muscle conditions, or those having surgery somewhere other than the operating room, would also not be able to participate. Also, if your child has already received muscle-relaxing medicines right before their surgery, they wouldn't be able to join.

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.

Is your child under 5 years old?
Is your child having a non-heart operation?
Will your child definitely have a general anaesthetic and muscle relaxants?
Does your child have any known allergies to muscle relaxants or monitoring pads?
Is your child generally healthy, without certain nerve or muscle problems?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, the doctors will use two different types of muscle monitors (EMG and KMG) to check their muscle function during their surgery. This will be done in a random order, meaning a computer will decide which monitor is used first. The monitoring is part of their anaesthetic care and won't involve any extra procedures. There won't be any additional hospital visits or follow-up appointments specifically for the study after their surgery, and the monitoring will only take place while they are having their operation. The total duration of their involvement would be limited to the time they are under anaesthesia for their planned surgery.

Potential risks and benefits

Participating in this study might help doctors learn more about the best ways to monitor muscle recovery in young children during surgery, potentially leading to safer anaesthesia practices in the future. The risks for your child are very low, as the monitoring equipment is already used in hospitals, and the procedures are part of routine care. There's a very small chance of skin irritation from the sticky pads used for monitoring. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

University Hospital Ulm
Verified postcode
Ulm, Germany

Common questions

What is neuromuscular monitoring?

It's a way doctors check how well your child's muscles are working and recovering after receiving muscle-relaxing medicines during surgery.

Why is this study important for children?

Because current monitoring devices work better for adults than for children, this study aims to find more accurate ways to keep children safe during and after surgery.

Will my child receive extra medicines or procedures for the study?

No, your child will only receive the standard care and medicines needed for their surgery. The study involves using different monitoring equipment.

What's the difference between EMG and KMG?

EMG measures electrical signals in the muscles, while KMG measures muscle movement. Both help doctors assess muscle recovery, and this study compares how well they work in young children.

Can I change my mind about my child's participation?

Yes, you can decide to withdraw your child from the study at any point without it affecting their care.