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Clinical Trials in Canada / NCT04289142
Recruiting Phase 4

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

NCT04289142 · tracked via the Priya Life Science Canada tracker
Phase
Phase 4
Started
2019-12-01
Last updated
2025-12-01

Condition(s) studied

DeliriumCognitive DysfunctionCognition DisorderNeurocognitive DisordersMental DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsDexmedetomidineHypnotics and SedativesCentral Nervous System DepressantsPhysiological Effects of DrugsAnalgesics, Non-NarcoticAnalgesicsMolecular Mechanisms of Pharmacological Action

Investigational drug(s) / intervention(s)

Dexmedetomidine Hydrochloride Group

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.

Study 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

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Royal Columbian Hospital Vancouver British Columbia Active Not Recruiting
St. Paul's Hospital Vancouver British Columbia Recruiting
London Health Sciences London Ontario Active Not Recruiting
Sunnybrook Health Sciences Centre Toronto Ontario Recruiting
St. Michael's Hospital Toronto Ontario Not Yet Recruiting
Toronto General Hospital Toronto Ontario Active Not Recruiting
Laval University Québec Quebec Recruiting
University of Saskatchewan Saskatoon Saskatchewan Active Not Recruiting

More Sunnybrook Health Sciences Centre trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04289142 on ClinicalTrials.gov ↗ ← All trials in Canada