Status:
RECRUITING
Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
London Health Sciences Centre
University Health Network, Toronto
Conditions:
Delirium
Cognitive Dysfunction
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
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 pati...
Detailed Description
Dexmedetomidine (DEX), a highly potent and selective α2-adrenoceptors (α2R) agonist used in clinical practice for sedation, analgesia, and anxiolysis, was recently shown to have beneficial effects on ...
Eligibility Criteria
Inclusion
- Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)
- Age ≥60
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT04289142
Start Date
December 1 2019
End Date
March 1 2029
Last Update
December 1 2025
Active Locations (8)
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1
Royal Columbian Hospital
Vancouver, British Columbia, Canada, V3L 0A2
2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
3
London Health Sciences
London, Ontario, Canada, N6A 5A5
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5