A blinded randomized study of neostigmine/glycopyrrolate 50 mikrogram/kg or sugammadex 2 mg/kg for reversal of neuromuscular blockade in elderly patients (≥ 75 years)
This research is for elderly patients (75 years and older) who are having a special type of keyhole surgery with robot assistance while under a general anaesthetic. The study is comparing two different medicines that doctors use to help patients wake up and recover their muscle strength after surgery. These medicines are called Robinul-Neostigmin and Bridion. Researchers want to find out which medicine helps patients recover their muscle movement and breathing control more quickly. They'll also be looking for any signs that a patient might still feel a bit weak after the surgery, like trouble holding their head up, or if they have any other issues like vision problems or changes in heart rhythm.
At a glance
What is this study about?
This study is focused on improving how older patients, specifically those aged 75 and above, recover after a type of keyhole surgery assisted by a robot. When you have general anaesthetic, medicines are used to relax your muscles completely. This is important for the surgeon to operate safely.
After the surgery, doctors need to reverse the effects of these muscle-relaxing medicines so you can start breathing properly and move again. This study is comparing two different medicines used for this purpose: Robinul-Neostigmin and Bridion. The main goal is to see which of these medicines helps patients regain their full muscle strength, especially for breathing, more quickly after the anaesthetic wears off.
The researchers are also interested in whether patients experience any lingering weakness, sometimes called 'residual weakness', up to 90 minutes after getting the reversal medicine. They'll be checking for things like how well you can grip, if your vision is blurry, or if you can lift your head. They will also keep an eye out for any breathing difficulties, heart rhythm changes, or if a patient needs help breathing again after leaving the operating room. This study is considered a 'Phase IV' study, which means the medicines are already approved and widely used, but doctors are looking for more detailed information on how they work in specific patient groups, like older adults.
Key takeaways
- Compares two medicines to help older patients wake up after robot-assisted keyhole surgery.
- Aims for faster recovery of muscle strength and breathing.
- Monitors for any lingering weakness or side effects after surgery.
- Study is for patients aged 75 and above, male or female.
- Medicines being tested are already in regular use.
- No direct benefit, but helps improve care for future patients.
Who may be eligible?
This study is for patients who are 75 years old or older. You will be included if you are having specific type of keyhole surgery that uses a robot, and you will be under general anaesthetic for this procedure.
Both men and women can take part in this research.
There are no other specific requirements mentioned for joining, such as restrictions based on other health conditions, but your doctors will always check if it's safe for you to participate.
- Are you 75 years old or older?
- Are you having a keyhole surgery that uses a robot?
- Will you be under general anaesthetic for your surgery?
- Are you comfortable with the care team checking your recovery closely after surgery?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, the main difference for you will be which of the two reversal medicines you receive after your surgery. You won't know which one you're getting, nor will the doctors giving it to you, to ensure the results are unbiased. Researchers will closely monitor your muscle strength recovery right after the surgery, looking at how quickly you regain full movement and control. They will particularly measure the time it takes for your muscles to recover to a certain level.
After your surgery, once you are in the recovery area, nurses and doctors will perform a few simple checks. These might include asking you to squeeze their hand, follow their finger with your eyes, or lift your head for a short period. They will also monitor your breathing and heart rhythm for a few hours after you've received the reversal medicine. The total duration of your direct participation in the study measurements will be focused on your immediate recovery in the hospital after your operation.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What exactly are they testing?
They're comparing two common medicines (Robinul-Neostigmin and Bridion) that help you wake up and regain muscle strength after general anaesthetic for surgery.
Why specifically focus on older patients?
Older patients sometimes recover differently from anaesthesia, so doctors want to find the best way to help them wake up and get their full strength back quickly.
Will I know which medicine I'm getting?
No, neither you nor your doctors will know which of the two medicines you receive. This helps make the study results fair and accurate.
What kind of surgery is this for?
This study is for patients having laparoscopic robot-assisted surgery, which is a type of keyhole surgery where a robot helps the surgeon.
What happens after the surgery as part of the study?
Doctors and nurses will check your muscle strength, vision, breathing, and heart rhythm for a few hours after you've had the reversal medicine to see how well you're recovering.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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