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/33849856/Actively Recruiting
Led by Sunnybrook Health Sciences Centre · Updated on 2025-12-01
2400
Participants Needed
8
Research Sites
34 weeks
Total Duration
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
Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients
S
Stephen Choi, MD,MSc,FRCPC
L
Lilia Kaustov, PhD
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Sunnybrook Health Sciences Centre
Lead Sponsor
London Health Sciences Centre
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Stephen Choi, Angela Jerath, Philip Jones...
https://pubmed.ncbi.nlm.nih.gov/33849856/Sunnybrook Health Sciences Centre
Lead Sponsor
London Health Sciences Centre
Collaborating Sponsor