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

Confusion Cognitive Dysfunction Molecular Mechanisms of Pharmacological Action Dexmedetomidine Nervous System Diseases Delirium Neurobehavioral Manifestations Cognition Disorder Mental Disorders Neurocognitive Disorders Analgesics, Non-Narcotic Hypnotics and Sedatives Physiological Effects of Drugs Analgesics Central Nervous System Depressants Neurologic Manifestations Signs and Symptoms

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 clinical trial is studying a drug called Dexmedetomidine Hydrochloride Group for people with analgesics, analgesics, non-narcotic, and other related conditions. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 60 Years and older.

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.

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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.