RecruitingPHASE4INTERVENTIONAL

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

This study is investigating if a medicine called Dexmedetomidine (DEX) can prevent long-term memory and thinking problems after heart surgery. Many people experience some memory issues or confusion after surgery, and heart operations carry a higher risk. Researchers believe DEX might reduce these problems and help patients recover faster. The study aims to see if DEX can improve how patients think and remember months after surgery, and if it helps them recover quicker from the effects of anaesthesia and surgery. If successful, DEX could become a way to keep patients' minds sharper after heart surgery, leading to better outcomes and shorter hospital stays.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

2,400

Start

01 Dec 2019

Estimated completion

01 Mar 2029

Delirium Cognitive Dysfunction Cognition Disorder Neurocognitive Disorders Mental Disorders Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Molecular Mechanisms of Pharmacological Action

What is this study about?

When you have an operation, doctors use medicines to put you into a deep sleep, which allows them to perform the surgery. While most people expect to fully return to their normal selves afterwards, sometimes people can experience memory problems or confusion that can last for weeks or even months. This is more common after heart surgery.

This study is looking into a medicine called Dexmedetomidine (let's call it DEX for short). DEX is already used in hospitals to help people relax and sleep during medical procedures. Researchers want to find out if giving DEX during heart surgery can prevent these lasting memory and thinking problems. They also want to see if it helps people recover more quickly from the effects of the anaesthetic and the surgery itself.

The hope is that DEX could be the first effective treatment to stop these post-surgery thinking problems. If it works, it could mean better overall recovery for patients, less confusion, and potentially shorter stays in the hospital. The study will carefully compare patients who receive DEX with those who don't, to understand its effects on their brains and recovery.

Key takeaways

This study investigates if Dexmedetomidine can prevent memory problems after heart surgery.
It targets patients aged 60 and over having specific heart operations.
Participation involves being randomly assigned to a treatment group and follow-up assessments for up to 12 months.
The goal is to improve brain recovery and potentially shorten hospital stays after heart surgery.
You won't know if you're receiving the study medicine, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 60 and over who are planning to have certain types of heart surgery. This includes operations to bypass blocked arteries (CABG), with or without valve repair, or valve replacement surgery.

However, not everyone having heart surgery will be able to join. You can't take part if you have major memory problems already, or if the specific type of heart surgery you're having involves a very complex procedure called aortic arch replacement. Also, if you have certain health conditions like severe heart block, very slow heart rate, advanced kidney disease, or a known allergy to Dexmedetomidine, you won't be able to participate.

It's also important that you're able to come to follow-up appointments and complete some brain and memory tests after your surgery. If you're unsure if you qualify, it's always best to discuss it with your doctor.

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 60 years old or older?
Are you having a bypass or heart valve replacement surgery?
Do you feel you can attend follow-up appointments and complete some memory tests?
Do you have any major memory problems already?
Do you have severe kidney or heart conditions, or an allergy to sedatives?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be randomly assigned to either receive Dexmedetomidine during your surgery or not. This is like flipping a coin, and neither you nor your doctors will know which group you are in. This helps ensure fair results.

During your hospital stay, the research team will regularly check for signs of confusion for about 10 days after your operation. They will also track how long you stay in intensive care and in the hospital overall, and monitor for any complications. You'll complete some tests to check your memory and thinking at 3, 6, and 12 months after your surgery. You'll also be asked about your mood and any pain you might still have at these check-up points. The total duration of your participation, including follow-up, would be about 12 months.

Potential risks and benefits

Participating in this study might offer potential benefits, such as helping researchers understand how to improve recovery and prevent long-term thinking problems after heart surgery, which could benefit future patients. For you personally, while there's no guarantee the study medicine will prevent problems, you will receive close medical attention. As with any medical treatment or study, there are potential risks, though Dexmedetomidine is a commonly used medication. You'll be closely monitored for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Royal Columbian Hospital
Verified postcode
Vancouver, Canada· Active not recruiting
St. Paul's Hospital
Verified postcode
Vancouver, Canada· Recruiting
London Health Sciences
Verified postcode
London, Canada· Active not recruiting
Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting
St. Michael's Hospital
Verified postcode
Toronto, Canada· Not yet recruiting
Toronto General Hospital
Verified postcode
Toronto, Canada· Active not recruiting
Laval University
Verified postcode
Québec, Canada· Recruiting
University of Saskatchewan
Verified postcode
Saskatoon, Canada· Active not recruiting

Common questions

What exactly is Dexmedetomidine?

Dexmedetomidine is a medicine already used in hospitals to help patients relax, feel less pain, and sleep during medical procedures or while recovering in intensive care.

Why are you studying this for heart surgery?

After heart surgery, some people experience temporary or even longer-lasting memory and thinking problems. We want to see if Dexmedetomidine can help prevent these issues and improve recovery.

Will I know if I'm getting the study medicine?

No, this is a 'blinded' study. Neither you nor your doctors will know whether you're receiving the study medicine or the usual care. This helps make the study results as fair as possible.

What kind of tests will I have after surgery?

You'll have some simple tests at 3, 6, and 12 months after your surgery to check your memory, thinking, and mood. We'll also ask about any pain you might have.

Can I stop participating if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, and it won't affect the medical care you receive.

How to find out more

Stephen Choi, MD,MSc,FRCPC

stephen.choi@sunnybrook.ca 416-480-6100 Official trial record

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