AuthorisedTherapeutic use (Phase IV)Interventional

Changes in airway cross sectional areas during residual neuromuscular blockade, and after reversal

This study is investigating a common side effect after general anaesthesia called 'residual neuromuscular blockade,' which means some muscle relaxation lingers, potentially affecting breathing. Researchers are observing how a drug called Sugammadex helps to reverse this effect. They're using special measurements of the upper airway (the back of your throat) during breathing, both before and after giving Sugammadex. The goal is to see if and how effectively Sugammadex opens up the airway. This kind of research helps doctors better understand how to use these medicines, aiming to improve patient safety and comfort after surgery by ensuring your breathing muscles fully recover. This study is for adults and is considered a 'Phase IV' study, meaning it's looking at how an already approved medicine works in everyday use.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

University Of Debrecen

Enrolment target

Start

03 Jan 2025

Detection of residual neuromuscular blockade after extubation by measuring upper airway diameter

What is this study about?

Imagine you're having an operation and need to be completely still. Doctors give you a medicine to relax your muscles deeply. Sometimes, after the operation, a little bit of that muscle relaxant can still be in your system. This is called 'residual neuromuscular blockade,' and it can make your breathing muscles feel a bit weak, potentially making it harder to breathe properly right after surgery.

This study is looking at how a specific medicine, Sugammadex, helps with this. Sugammadex is given to reverse the effects of muscle relaxants. Researchers want to see exactly how well it works to open up your airway – that's the passage at the back of your throat where air goes in and out.

To do this, they will take measurements of the inside of your throat, looking at its size when you breathe in and out, both before and after Sugammadex is given. By comparing these measurements, doctors can learn more about how Sugammadex helps your breathing muscles recover. The aim is to help make your recovery from anaesthesia smoother and safer, ensuring your airway is clear and strong.

Key takeaways

Looks at how a drug (Sugammadex) helps reverse muscle relaxants after surgery.
Aims to understand how Sugammadex affects airway size and breathing.
Involves measuring the back of your throat during recovery.
Helps improve patient safety and comfort after general anaesthesia.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

This study is looking for adult participants, meaning anyone aged 18 years or older. There is no upper age limit, so older adults are welcome to participate too.

Both men and women can take part in this study. The researchers want to understand how the medicine works across all adults who might be having surgery.

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 18 years old or older?
Are you scheduled for surgery where you'll receive a muscle relaxant?
Are you happy for doctors to take extra measurements of your throat during recovery?
Are you able to understand and give consent for the study?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't have to make extra visits, as the study will happen during your hospital stay for surgery. You will receive the usual care, including the muscle relaxant Esmeron and its reversal drug Sugammadex, as part of your anaesthesia. The main part of your involvement will be having some extra measurements taken of your airway (the back of your throat) using special equipment. These measurements will be taken at different times after your operation, while the muscle relaxant is still wearing off and again after you've been given Sugammadex to reverse it. The medical team will explain everything to you before any measurements are taken. The total duration of your participation will be limited to the time in the operating theatre and immediate recovery.

Potential risks and benefits

Taking part in this study could help doctors better understand how medicines used during surgery affect breathing, which may benefit future patients. The main procedures in this study involve standard medical treatments you'd already receive during surgery. Any additional measurements are non-invasive and aim to be as comfortable as possible. As with any medical procedure, there's always a small chance of unexpected effects, although these would be carefully monitored. You are absolutely free to decide to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary

Common questions

What is 'residual neuromuscular blockade'?

It means some muscle relaxing medicine from an operation is still in your system, which can make your muscles feel a bit weak afterwards.

What is Sugammadex?

It's a medicine given to help fully reverse the effects of muscle relaxants used during surgery, helping your muscles regain their strength.

Why is my airway being measured?

Researchers want to see if Sugammadex helps open up the passage at the back of your throat, making it easier to breathe after surgery.

Will taking part change my surgery plan?

No, you will receive the standard care and medicines. The study just involves extra observations and measurements during your recovery.

Do I have to be a certain age?

You need to be 18 years old or older to take part, but there's no upper age limit.