Dexmedetomidine for Postoperative Cognitive Dysfunction
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the drug Dexmedetomidine for postoperative cognitive dysfunction?
Is dexmedetomidine safe for use in humans?
Dexmedetomidine is generally considered safe and is widely used as a sedative in surgical procedures, but it can cause side effects like low blood pressure (hypotension) and slow heart rate (bradycardia). In rare cases, it has been associated with serious events like cardiac arrest, especially in patients with certain heart conditions.678910
How is the drug Dexmedetomidine unique for treating postoperative cognitive dysfunction?
Dexmedetomidine is unique because it acts on a2-adrenergic receptors in the brain, providing sedative and neuroprotective effects, which may help improve cognitive function after surgery. Unlike other treatments, it also helps maintain hemodynamic balance (stable blood pressure and heart rate) and has minimal impact on breathing.2591112
What is the purpose of this trial?
Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.
Research Team
Stephen Choi, MD,MSc,FRCPC
Principal Investigator
Sunnybrook Health Sciences Centre
Sinziana Avramescu, MD,PhD,FRCPC
Principal Investigator
Sunnybrook Health Sciences Centre
Eligibility Criteria
This trial is for individuals aged 60 or older who are scheduled for open heart surgery (CABG or valve replacement) and will recover in the CVICU. They must not have severe pre-existing cognitive issues, a history of certain heart conditions, liver cirrhosis, very slow heartbeat, advanced kidney disease, or be unable to attend follow-up assessments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dexmedetomidine or standard sedation protocols immediately post-surgery, with dexmedetomidine administered for up to 24 hours
In-hospital Monitoring
Participants are monitored for delirium, hemodynamic stability, and other complications from post-operative day 0 to 10
Follow-up
Participants are monitored for POCD, depression, and mild cognitive impairment at 3, 6, and 12 months post-surgery
Treatment Details
Interventions
- Dexmedetomidine
Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor