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Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

RecruitingPhase 4Ages 60 Years - anyAllSunnybrook Health Sciences Centre
NCT04289142 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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)
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What it tests

  • Dexmedetomidine Hydrochloride Group
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Where

8 sites
Royal Columbian Hospital
Vancouver, Canada
St. Paul's Hospital
Vancouver, Canada
London Health Sciences
London, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
St. Michael's Hospital
Toronto, Canada
Toronto General Hospital
Toronto, Canada
Laval University
Québec, Canada
University of Saskatchewan
Saskatoon, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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