Active not recruitingNAINTERVENTIONAL

Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

After open heart surgery, about 1 in 5 adults can experience a temporary state of confusion called delirium, which can lead to longer hospital stays and other long-term problems. This study, called B-FREE, aims to find out if limiting the use of certain calming medications (benzodiazepines) during heart surgery can help reduce this confusion. Doctors currently use these medicines for their calming and memory-dulling effects during operations. However, some doctors use them a lot, and others hardly at all. This research will compare different approaches across hospitals to see which one leads to fewer problems for patients after surgery. The goal is to improve care and provide clear guidelines for future heart operations.

At a glance

Status

Active not recruiting

Phase

Sponsor

Population Health Research Institute

Enrolment target

15,886

Start

18 Nov 2019

Estimated completion

30 Apr 2025

Delirium Post-cardiac Surgery

What is this study about?

Imagine waking up from heart surgery feeling confused or disoriented – this is called delirium. It's a common problem, affecting about one in five people after open heart surgery. While it usually doesn't last forever, it can lead to other issues like having to stay in hospital longer, struggling with thinking clearly, moving around, or taking care of yourself once you go home. Sadly, it can even increase the risk of needing to go to a nursing home or, in some sad cases, dying.

Doctors often use medications called benzodiazepines during heart surgery. These medicines help you relax and forget what happened during the operation. However, there's a debate among doctors about how much to use them. Some doctors use them frequently, while others prefer to use very little or none at all, because there's a suspicion that these medications might contribute to the confusion experienced after surgery.

This study, called B-FREE, wants to get to the bottom of this. It's comparing two different ways hospitals manage these medications during heart surgery: one approach where they limit the use of benzodiazepines, and another where they use them as they usually would. By doing this across different hospitals, the researchers hope to find out if using less of these medications actually reduces the chances of patients experiencing confusion after their operation. The findings could really make a difference for many patients and help doctors develop the best possible guidelines for heart surgery care in the future.

Key takeaways

This study investigates if limiting certain calming drugs during heart surgery reduces post-operative confusion.
Delirium (confusion) is a common, but serious, problem after heart surgery.
The study compares two hospital-wide approaches to medication use during surgery.
The goal is to find better ways to care for patients following heart operations.
Patients aren't individually recruited; the study focuses on hospital practices.
Findings could inform future medical guidelines and improve patient outcomes.

Who may be eligible?

This study isn't about inviting individual patients to take part directly. Instead, it's about how entire hospitals manage certain medications during heart surgery. Therefore, the selection criteria are for the hospitals themselves.

To be part of this study, a hospital must be a major surgery centre that performs at least 250 heart operations each year. The doctors at the hospital must also be in agreement that they are happy to follow whichever policy (using less benzodiazepine or using it as usual) is decided for their hospital at different times during the study. This means they are open to trying both approaches.

The hospital also needs to already have a system in place to check for confusion or delirium in patients over 18 at least every 12 hours for the first three days after heart surgery. This is important so the researchers can accurately see if the change in medication policy has an effect.

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.

Is your hospital a large surgical centre that performs many heart operations?
Are the doctors at your hospital open to trying different approaches to medication during surgery?
Does your hospital regularly check for confusion in patients after heart surgery?
Are you an adult aged 18 or over?
Are you having open heart surgery?

Answer every question to see your result.

What does participation involve?

This study is about how hospitals, rather than individual patients, manage care. Patients would not sign up directly. Instead, if you're having open heart surgery at a hospital participating in this study, the doctors there will follow one of the two medication policies already in place for that period: either limiting certain calming medications (benzodiazepines) during your surgery, or using them as they normally would. You won't have extra visits or assessments specifically for the study, as the hospital already checks for post-operative confusion as part of its usual care. The total duration of your involvement would be during and immediately after your heart surgery, as the study focuses on your experience with confusion within the first 72 hours.

Potential risks and benefits

The main benefit of this study is that it could help improve how heart surgery is done, potentially reducing confusion and other problems after the operation for many future patients. Since this study looks at existing practices within hospitals, there are no additional risks to patients beyond those normally associated with open heart surgery. You will receive standard medical care throughout your surgery and recovery, under the supervision of your medical team. You and your doctors always have the right to make decisions about your care. Even though individual patients aren't directly 'enrolled,' you can always discuss medication choices with your anaesthetist before surgery.

Locations (20)

Washington University School of Medicine
Verified postcode
St Louis, United States
Weill Cornell Medicine
Verified postcode
New York, United States
Mazankowski Alberta Heart Institute
Verified postcode
Edmonton, Canada
Royal Columbian Hospital
Verified postcode
New Westminster, Canada
Vancouver General Hospital
Verified postcode
Vancouver, Canada
St. Paul's Hospital
Verified postcode
Vancouver, Canada
St. Boniface General Hospital
Verified postcode
Winnipeg, Canada
Queen Elizabeth II Health Sciences Centre
Verified postcode
Halifax, Canada
Hamilton Health Sciences, Hamilton General Hospital
Verified postcode
Hamilton, Canada
Kingston General Hospital
Verified postcode
Kingston, Canada
London Health Sciences Centre
Verified postcode
London, Canada
Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada

Common questions

What is benzodiazepine?

It's a type of medicine often used during surgery to help you relax and forget what happened. It has calming and memory-dulling effects.

What is delirium?

Delirium is a sudden state of confusion, disorientation, or changes in thinking, especially after surgery or illness. It's usually temporary.

Why is this study important for me?

While you won't directly 'join' the study, its findings could lead to safer and better care for people having heart surgery in the future, potentially reducing complications like confusion.

Will I know if my hospital is part of this study?

Your hospital's medical team will manage your care according to their current policies. You can always ask your anaesthetist or surgeon about the medications they plan to use.

Will my care be different if my hospital is in the study?

Your care will be delivered by your doctors as usual, but the hospital may be following a specific guideline for benzodiazepine use as part of the study. This is about comparing different approaches to improve overall care.