RecruitingOBSERVATIONAL

Prediction of Propofol Effect-Site Concentration Associated With Deep Anesthesia

This study aims to understand why people need different amounts of propofol, a common anaesthetic, to go into a deep sleep for surgery. Researchers will observe adults undergoing general anaesthesia. Before surgery, participants will have tests to check their brain activity (EEG) and thinking abilities. The study will then measure the exact amount of propofol needed for each person to reach deep anaesthesia. The goal is to see if pre-surgery brain patterns and cognitive skills can help predict the ideal dose of propofol, making anaesthesia more personalised and safer for patients.

At a glance

Status

Recruiting

Sponsor

Ciusss de L'Est de l'Île de Montréal

Enrolment target

110

Start

07 Apr 2025

Estimated completion

01 Jan 2027

Anesthesia

What is this study about?

When you have an operation, you're usually given a general anaesthetic to make you go to sleep. Propofol is a very common medication used for this. However, people are very different, and the amount of propofol needed to get someone into a deep sleep can vary a lot from person to person. This study wants to understand why these differences exist.

Imagine if doctors could know, even before starting an anaesthetic, exactly how much propofol you'd need. This could make anaesthesia smoother and safer for patients. Currently, doctors don't have a direct way to measure how much propofol is in your brain, where it does its work. They rely on models, but these don't always account for individual differences very well. This research hopes to find a better way to predict the right dose for each person.

The researchers believe that certain things could help predict how much propofol you'll need. These include your individual characteristics, how well your brain works (your 'thinking skills'), and patterns in your brain activity that can be measured with a special brain scan called an electroencephalogram (EEG) before the operation. By gathering this information, they hope to develop a clever computer program that can help doctors give you just the right amount of anaesthetic.

Key takeaways

This study explores how much anaesthetic (propofol) people need for surgery.
It aims to understand why individual anaesthetic needs vary.
Researchers will look at brain activity (EEG) and thinking skills before surgery.
The goal is to help doctors predict the right anaesthetic dose for each patient.
This could lead to more personalised and safer anaesthesia in the future.
Participation involves brain and thinking tests before surgery, and observation during anaesthetic.

Who may be eligible?

This study is looking for adults aged 18 or over who are scheduled to have any type of surgery requiring a general anaesthetic. You'll need to be able to understand and communicate in either French or English to take part.

There are some reasons why you wouldn't be able to join. For example, if you have any known allergies or medical conditions that prevent you from safely receiving the anaesthetic medications used in the study. Also, if you need a very quick anaesthetic (called a rapid sequence induction) or if doctors anticipate it might be difficult to put a breathing tube in or help you breathe during surgery, you wouldn't be eligible.

Finally, if your body mass index (BMI) is 35 or higher (which doctors would call severely overweight or obese), you wouldn't be able to participate in this particular study.

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 under general anaesthesia?
Can you communicate comfortably in French or English?
Do you have any conditions that make general anaesthesia risky for you?
Do you have a BMI (body mass index) under 35?
Is it expected to be easy to give you a breathing tube during surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what would happen:

Before your surgery, you would complete some simple tests to check your thinking and memory skills. You would also have an 'awake EEG', which involves placing sensors on your head to measure your brain activity while you're awake – this is completely painless. These tests would happen during a separate appointment, likely before your surgery date.

On the day of your surgery, as usual, you would be prepared for your operation. When it's time for your general anaesthetic, the doctors would give you propofol continuously through a drip until you are in a deep sleep. During this time, the researchers would carefully record the concentration of propofol that was needed to achieve that deep sleep. They would also monitor your brain with another EEG to see how your brain activity changes as you go to sleep. You won't need any extra medication beyond what's usually given for your general anaesthetic. The total duration of your active involvement in the study would be the time taken for the pre-surgery assessments and the period of your anaesthetic induction on the day of your surgery.

Potential risks and benefits

Taking part in this study could help doctors understand how to give more personalised and potentially safer anaesthesia in the future, which could benefit many patients. You wouldn't directly benefit from different anaesthetic care in this specific study, as the goal is to observe what happens. The risks involved are generally similar to those for any general anaesthetic – for example, feeling drowsy or sick afterwards, which are common and usually temporary. The extra tests, like the brain activity measurements (EEG) and cognitive tests, are non-invasive and carry very little risk. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hopital Maisonneuve-Rosemont
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is propofol?

Propofol is a common medication given through a vein to make you go to sleep for surgery or other medical procedures. It's often called a 'general anaesthetic'.

What is an EEG?

An EEG (electroencephalogram) is a simple test that measures the electrical activity of your brain. Sticky pads are placed on your scalp, and it's completely painless, like listening to your brain waves.

Will this study change my anaesthetic care?

No, your anaesthetic care will be managed as usual by your doctors. This study is observational, meaning researchers are just carefully watching and recording what happens during your usual anaesthetic.

What does 'deep anaesthesia' mean?

Deep anaesthesia means you are very soundly asleep and unaware during your surgery. Doctors monitor this closely using special equipment.

Is it safe to vary the dose of anaesthetic?

Anaesthetists adjust medication doses all the time to make sure each patient is safely and comfortably asleep. This study aims to help them do that even more precisely in the future.

How to find out more

Louis Morisson, MD, MSc

louis.morisson@umontreal.ca 514-252-3400 Official trial record

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