Status:
ACTIVE_NOT_RECRUITING
Dexmedetomidine to Reduce the Incidence of POCD After Open Cardiac Surgery
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Delirium
Postoperative 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 (including off-pump) or valve replacement (+/- CABG) via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)
- age ≥60
Exclusion
- Lack of patient consent
- Pregnant or nursing females
- Pre-operative major cognitive dysfunction (CogState Brief Battery score \< 80)
- Aortic arch replacement/re-implantation (Bentalls)
- 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 timepoints)
Key Trial Info
Start Date :
August 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03480061
Start Date
August 9 2018
End Date
December 1 2026
Last Update
December 24 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5