Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

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.

Conditions

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

Interventions

DRUG

Dexmedetomidine 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.

Sponsors & Collaborators

• London Health Sciences Centre

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• McMaster University

  collaborator OTHER

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• The Dana Foundation

  collaborator OTHER

• Brain Canada

  collaborator OTHER

• Alzheimer's Association

  collaborator OTHER

• Hamilton Health Sciences Corporation

  collaborator OTHER

• University of Saskatchewan

  collaborator OTHER

• Fraser Health

  collaborator OTHER

• Providence Health & Services

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  lead OTHER

Principal Investigators

• Stephen Choi, MD,MSc,FRCPC · Sunnybrook Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-01

Primary Completion

2028-07-31

Completion

2029-03-31

Countries

• Canada

Study Locations