Effects of Dexmedetomidine on cognitive recovery after cardiac surgery
Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial
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 |
| Enrollment | 2400 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 8 sites (Vancouver, British Columbia and 7 other locations) |
| Trial ID | NCT04289142 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 60 and older scheduled for coronary artery bypass grafting (CABG) or valve replacement surgery.
Not a fit: Patients with pre-existing major cognitive dysfunction or those with contraindications to Dexmedetomidine will not benefit from this study.
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 performed: Other studies have shown promising results with Dexmedetomidine in reducing cognitive impairment, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Vancouver, British Columbia and 7 other locations
- Royal Columbian Hospital — Vancouver, British Columbia, Canada (Active_not_recruiting)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- London Health Sciences — London, Ontario, Canada (Active_not_recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
- St. Michael's Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
- Toronto General Hospital — Toronto, Ontario, Canada (Active_not_recruiting)
- Laval University — Québec, Quebec, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.