Effects of Dexmedetomidine on cognitive recovery after cardiac surgery
Official title: Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial
Run by Sunnybrook Health Sciences Centre · NCT04289142 · Data updated 2026-11-12
This study is testing if a medication called Dexmedetomidine can help people recover their thinking skills better after having heart surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 2400 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 8 sites (Vancouver, British Columbia and 7 other locations) |
| Status | Recruiting |
| Started | December 1, 2019 |
| Main results expected | July 2028 |
| Study ends | March 2029 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT04289142 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients aged 60 and older scheduled for coronary artery bypass grafting (CABG) or valve replacement surgery.
✕Probably not a fit
Patients with pre-existing major cognitive dysfunction or those with contraindications to Dexmedetomidine will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the impact of Dexmedetomidine (DEX) on cognitive outcomes in patients undergoing cardiac surgery. It aims to determine whether DEX can prevent long-term postoperative cognitive dysfunction (POCD) and enhance early recovery after surgery. Participants will be randomized to receive either DEX or standard care, with outcomes assessed for delirium, cognitive function, and overall recovery. The study will involve multiple sites and will track various postoperative complications and recovery metrics over several months.
Why it matters
Potential benefit: If successful, this study could provide an effective preventative therapy for cognitive dysfunction after cardiac surgery, improving patient outcomes and reducing healthcare costs.
How similar studies have gone: Other studies have shown promising results with Dexmedetomidine in reducing cognitive impairment, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
St. Paul's Hospital
Vancouver, British Columbia, Canada Recruiting -
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting -
Laval University
Québec, Quebec, Canada Recruiting -
Royal Columbian Hospital
Vancouver, British Columbia, Canada Active not recruiting -
London Health Sciences
London, Ontario, Canada Active not recruiting -
St. Michael's Hospital
Toronto, Ontario, Canada Not yet recruiting
Show 2 more locations
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Toronto General Hospital
Toronto, Ontario, Canada Active not recruiting -
University of Saskatchewan
Saskatoon, Saskatchewan, Canada Active not recruiting
Study contacts
- Principal investigator: Stephen Choi, MD,MSc,FRCPC — Sunnybrook Health Sciences Centre
- Study coordinator: Stephen Choi, MD,MSc,FRCPC
- Email: stephen.choi@sunnybrook.ca
- Phone: 416-480-6100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.