Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorSunnybrook Health Sciences Centre

About this trial

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 criteria

Qualifiers

Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)

Age ≥60

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Dexmedetomidine Hydrochloride Group

Treatment groups

2,400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sunnybrook Health Sciences Centre

Lead sponsor

London Health Sciences Centre

Collaborator

University Health Network, Toronto

Collaborator

McMaster University

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

The Dana Foundation

Collaborator

Brain Canada

Collaborator

Alzheimer's Association

Collaborator

Hamilton Health Sciences Corporation

Collaborator

University of Saskatchewan

Collaborator

Fraser Health

Collaborator

Providence Health & Services

Collaborator