Actively Recruiting

Phase 4
Age: 60Years +
All Genders
NCT04289142

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Led by Sunnybrook Health Sciences Centre · Updated on 2025-12-01

2400

Participants Needed

8

Research Sites

482 weeks

Total Duration

On this page

Sponsors

S

Sunnybrook Health Sciences Centre

Lead Sponsor

L

London Health Sciences Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)
  • Age 60 years or older
Not Eligible

You will not qualify if you...

  • Lack of patient consent
  • Pre-operative major cognitive dysfunction (CogState Brief Battery score < 80) at screening
  • Aortic arch replacement/re-implantation surgery requiring hypothermic circulatory arrest (e.g., Bentall procedure)
  • Allergy or contraindication to dexmedetomidine, including untreated 2nd degree type 2 or 3rd degree heart block (pacemaker), cirrhosis, heart rate less than 50, grade 4 left ventricular dysfunction, renal failure, or on renal replacement therapy
  • Unlikely to comply with study assessments, such as no fixed address or inability to complete cognitive tests at 3, 6, and 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 8 locations

1

Royal Columbian Hospital

Vancouver, British Columbia, Canada, V3L 0A2

Active, Not Recruiting

2

St. Paul's Hospital

Vancouver, British Columbia, Canada, V6Z 1Y6

Actively Recruiting

3

London Health Sciences

London, Ontario, Canada, N6A 5A5

Active, Not Recruiting

4

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

5

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Not Yet Recruiting

6

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Active, Not Recruiting

7

Laval University

Québec, Quebec, Canada, G1V 0A6

Actively Recruiting

8

University of Saskatchewan

Saskatoon, Saskatchewan, Canada, S7N 0W8

Active, Not Recruiting

Loading map...

Research Team

S

Stephen Choi, MD,MSc,FRCPC

CONTACT

L

Lilia Kaustov, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here