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RecruitingNAINTERVENTIONAL

Neurocognitive Disorders After Major Surgery in Elderly

This study is for people aged 70 and over who are having major surgery (not on the heart). It wants to find out if using a special brain monitor (EEG) to guide anaesthesia can lower the risk of temporary memory and thinking problems after the operation. The EEG helps doctors give just the right amount of anaesthesia, avoiding too much or too little. Researchers will compare this guided approach with the usual way of giving anaesthesia to see which is better at preventing these issues. They will also look at other things like how much anaesthetic is used and general recovery.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Ciusss de L'Est de l'Île de Montréal
Enrolment target
314
Start
24 Nov 2021
Estimated completion
01 Aug 2025

What is this study about?

This research study is about helping older patients, specifically those aged 70 and above, who are having a major operation that isn't on their heart. Sometimes, after big surgery, people can experience temporary problems with their memory, concentration, or thinking. This is called a neurocognitive disorder, and while it often gets better, it can be worrying.

The study aims to see if a particular way of giving the general anaesthetic can reduce the chances of these thinking problems. Doctors will use a special monitor that reads brain waves (like an EEG, which is similar to what's used in sleep studies) to carefully control the amount of anaesthetic medicine given. The idea is to adjust the anaesthetic more precisely, aiming for a lighter but still effective level, and avoiding deep sedation that might be linked to these thinking issues. Patients in the study will be split into two groups by chance: one group will receive this brain-wave guided anaesthesia, and the other will receive the usual anaesthesia care. Both groups will also have their pain relief and blood pressure carefully managed.

By comparing what happens in both groups, the researchers hope to learn if this more controlled, brain-wave guided anaesthesia can lead to fewer memory and thinking problems shortly after surgery. They will also check if there are differences in how much anaesthetic is used, how quickly people recover, and their general well-being after the operation. This study is important because it could help improve safety and recovery for older people having surgery in the future.

Key takeaways

  • The study is for people aged 70 and over having major non-heart surgery.
  • It aims to see if specific anaesthesia methods can reduce post-surgery memory problems.
  • Anaesthesia will either be guided by a brain monitor or by standard care.
  • Memory and thinking will be checked regularly for 90 days after surgery.
  • Pain relief and blood pressure will be closely managed in all participants.

Who may be eligible?

This study is looking for volunteers aged 70 or older. You would need to be scheduled for a major operation that involves your tummy, reproductive organs, waterworks, or chest, and isn't a heart surgery. This surgery needs to be planned in advance, not an emergency, and is expected to last longer than one hour.

Before you can join, you'll have a check-up with the hospital's internal medicine or anaesthesia team to make sure it's suitable. Some reasons you might not be able to join include having a known diagnosis of severe memory problems (like dementia) or other serious brain conditions, needing emergency surgery, or having severe sight or hearing problems that would make it hard to do the memory tests.

Also, if you have a known allergy to the anaesthetic medicines used in the study, or if you can't speak English or French, you wouldn't be able to take part. The study needs participants who can understand and communicate in these languages for the cognitive assessments.

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.

  1. Are you 70 years of age or older?
  2. Are you having a major planned surgery (not on your heart, and not an emergency)?
  3. Is your surgery expected to last more than one hour?
  4. Are you able to speak and understand English or French?
  5. Do you not have a pre-existing severe memory problem like dementia?
Answer every question to see your result.

What does participation involve?

If you join this study, your anaesthesia during surgery will be carefully monitored. You will either have your anaesthesia guided by a special brain-wave monitor, or you will receive standard anaesthesia care. Your pain relief and blood pressure will also be closely managed during the operation. After your surgery, you will have your memory and thinking skills checked, usually by a simple test, on several occasions: the day after surgery, then again on day 2, day 7, day 15, day 30, and finally on day 90. These assessments help the researchers track any changes and see how you are recovering over time. The total duration of your participation, including follow-up, will be around 90 days after your surgery.

Potential risks and benefits

Taking part in this study could potentially offer a benefit if the brain-wave guided anaesthesia proves to reduce the risk of memory and thinking problems after surgery, though this is not guaranteed for any individual. All medical procedures carry some risk, and while the study aims to improve care, the anaesthesia methods used are either standard or carefully monitored. You will receive very close attention during your operation and recovery. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • CIUSSS de l'Est de l'Île de Montréal
    Verified postcode
    Montreal, Canada· Recruiting

Common questions

What kind of surgery is included?

It includes major planned surgery on your tummy, reproductive organs, waterworks, or chest, but not heart surgery.

What are 'neurocognitive disorders'?

These are temporary problems with memory, concentration, or thinking that can sometimes happen after surgery.

Will I know which anaesthesia group I'm in?

No, you won't know which group you are in. This helps ensure the results are fair and unbiased.

How often will I be checked after surgery?

You'll have assessments on day 1, 2, 7, 15, 30, and 90 after your operation.

Can I stop participating if I change my mind?

Yes, you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Philippe Richebé, MD, PHD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Neurocognitive Disorders After Major Surgery in Elderly…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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