Cognitive Outcomes after DEXmedetomidine sedation in cardiac surgery: CODEX randomised controlled trial protocol.
Stephen Choi, Angela Jerath, Philip Jones...
https://pubmed.ncbi.nlm.nih.gov/33849856Actively Recruiting
Phase 4
Age: 60Years +
All Genders
ID04289142
Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial
Led by Sunnybrook Health Sciences Centre · Updated on 2025-12-01
2400
Participants Needed
8
Research Sites
34 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
L
London Health Sciences Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of Dexmedetomidine (DEX), a sedative drug, to see if it can prevent long-term memory and thinking problems after cardiac surgery. These cognitive problems, known as postoperative cognitive dysfunction (POCD), often occur after anesthesia and surgery, especially heart surgery, and can lead to longer hospital stays and loss of independence. This trial aims to evaluate whether DEX can improve recovery and reduce these cognitive issues in older adults undergoing certain types of heart surgery. Participants will be randomly assigned to one of two groups. One group will receive a loading dose of Dexmedetomidine before moving to the Cardiovascular Intensive Care Unit (CVICU), followed by a continuous infusion for up to 12 hours or until they are ready to leave the CVICU. The other group will receive standard sedation care as decided by their doctor. This study is double-blind and conducted at multiple sites. During the study, participants will be monitored for delirium, memory and cognitive function, depression, pain at the surgical site, and recovery at several time points including up to 12 months after surgery. Hospital outcomes such as length of stay, complications, opioid use, and survival will also be tracked. Cognitive tests and questionnaires will be done before surgery and during follow-up visits to measure the effects of the treatment over time.
CONDITIONS
Brief Title
Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Planned coronary artery bypass grafting (CABG) with or without valve surgery, including off-pump procedures, or valve replacement surgery through sternotomy or thoracotomy
- Age 60 years or older
- Initial recovery planned in the Cardiovascular Intensive Care Unit (CVICU)
You will not qualify if you...
- Lack of patient consent
- Major cognitive dysfunction before surgery (CogState Brief Battery score below 80)
- Surgery involving aortic arch replacement or procedures requiring hypothermic circulatory arrest
- Allergy or contraindication to dexmedetomidine, including untreated certain heart blocks, cirrhosis, heart rate below 50, severe left ventricular dysfunction, kidney failure or on renal replacement therapy
- Unlikely to comply with study assessments such as no fixed address or inability to complete cognitive tests at 3, 6, and 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 hours or until discharge from CVICU
Participants receive dexmedetomidine sedation starting prior to transfer to the Cardiovascular Intensive Care Unit (CVICU) with a loading dose followed by continuous infusion for up to 12 hours or until discharge from CVICU. Additional sedatives may be given as needed.
Continuous monitoring during CVICU stay
Post-operative Follow-up
Duration - 12 months
Participants are assessed for cognitive function, delirium, depressive symptoms, surgical site pain, recovery, and other health outcomes after surgery over a period of 12 months.
Assessments at 1 week, 3 months, 6 months, and 12 months post-surgery
Trial Site Locations
Total: 8 locations
1
Royal Columbian Hospital
Vancouver, British Columbia, Canada, V3L 0A2
Active, Not Recruiting
2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
3
London Health Sciences
London, Ontario, Canada, N6A 5A5
Active, Not Recruiting
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Not Yet Recruiting
6
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Active, Not Recruiting
7
Laval University
Québec, Quebec, Canada, G1V 0A6
Actively Recruiting
8
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Active, Not Recruiting
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Research Team
S
Stephen Choi, MD,MSc,FRCPC
L
Lilia Kaustov, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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