RecruitingPhase 4NCT04289142

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

2,400 participants

Start Date

Dec 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether dexmedetomidine — a sedation drug that also has protective effects on the brain — can reduce cognitive decline (post-operative cognitive dysfunction, or POCD) in older adults who undergo open-heart surgery such as coronary artery bypass grafting (CABG) or valve replacement. Cognitive decline after cardiac surgery is common in older patients and can significantly impact quality of life. Dexmedetomidine may protect the brain during recovery in the ICU. You may be eligible if: - You are 60 years or older - You are scheduled for CABG (with or without valve repair/replacement) or valve replacement surgery via sternotomy or thoracotomy - Your recovery will begin in the Cardiovascular Intensive Care Unit (CVICU) You may NOT be eligible if: - You have not provided consent - You have significant pre-existing cognitive problems (CogState Brief Battery score below 80) - You are having aortic arch replacement or surgery requiring hypothermic circulatory arrest (such as a Bentall procedure) - You have an allergy or contraindication to dexmedetomidine (such as untreated heart block, cirrhosis, heart rate below 50, severe heart failure, or renal failure on dialysis) - You are unlikely to be able to complete follow-up cognitive assessments at 3, 6, and 12 months Talk to your cardiac surgeon or anesthesiologist about this study if you are an older adult planning to undergo heart surgery and are concerned about memory or cognitive changes afterward.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDexmedetomidine Hydrochloride Group

Dexmedetomidine will be initiated prior to transfer to the CVICU with loading dose of 1.2 ug/kg over approximately 20-60 minutes. This will be followed by an infusion at 0.3 ug/kg/h in CVICU for up to 12 hours from the time DEX infusion started or until the patient is ready for discharge from the CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.


Locations(8)

Royal Columbian Hospital

Vancouver, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

London Health Sciences

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Laval University

Québec, Quebec, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04289142


Related Trials