Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Recruiting now · Phase 4

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04289142

Run by

Sunnybrook Health Sciences Centre

People needed

2400

Starts

2019-12-01

Expected to finish

2029-03-01

Last updated by the study team

2025-12-01

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)
• Age ≥60

You may not qualify if…

• 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/contraindication to dexmedetomidine (untreated 2nd degree type 2 or 3rd degree heart block (pacemaker), cirrhosis, HR < 50 , grade 4 LV, renal failure or on renal replacement therapy)
• Unlikely to comply with study assessments (e.g. no fixed address, cannot complete cognitive tests at the 3, 6, and 12 month time points)

Where it is running

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
• Laval University — Québec, Quebec, Canada (enrolling)
• St. Paul's Hospital — Vancouver, British Columbia, Canada (enrolling)
• Toronto General Hospital — Toronto, Ontario, Canada
• Royal Columbian Hospital — Vancouver, British Columbia, Canada
• University of Saskatchewan — Saskatoon, Saskatchewan, Canada
• London Health Sciences — London, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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