Recruiting

Dexmedetomidine

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04289142

Conditions

Delirium

Cognitive Dysfunction

Cognition Disorder

Neurocognitive Disorders

Mental Disorders

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine Hydrochloride Group

Study Details

Brief 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

Study ID

NCT04289142

Start date

Dec 1, 2019

Status verified date

Jul, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

2400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Dexmedetomidine Hydrochloride Group

Patients will receive a loading dose of 1.2 μg/kg dexmedetomidine prior to transfer to CVICU over 20-60 min immediately postoperative, followed by continuous infusion of 0.3 μg/kg/h for up to 12 hours or until patient is ready for discharge from CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.

no intervention: Standard of Care Group

Standard sedation protocols will be followed at the discretion of the attending physician.

Interventions

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.

Primary outcome measure

  • Post-operative cognitive dysfunction [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Stephen Choi, MD,MSc,FRCPC

416-480-6100stephen.choi@sunnybrook.ca

Lilia Kaustov, PhD

416-480-6100lilia.kaustov@sunnybrook.ca

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Nicola Edwards

nedwards@providencehealth.bc.ca

Principal Investigator:

Raja Rajamohan, M.D

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Lilia Kaustov, PhD

416-480-6100lilia.kaustov@sunnybrook.ca

Principal Investigator:

Stephen Choi, MD,FRCPC,MSc

Laval University

Recruiting

Québec, Quebec, Canada, G1V 0A6

Contacts

Francois Laforge

francois.laforge.1@ulaval.ca

Principal Investigator:

Etienne Couture

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 1, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-12-01.