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

Inclusion Criteria2

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 Criteria5

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)

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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.