Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Central Nervous System Depressants
  • Analgesics
  • Analgesics Non-narcotic
  • Cognition Disorder
  • Cognitive Dysfunction
  • Confusion
  • Neurologic Manifestations
  • Delirium
  • Signs and Symptoms
  • Dexmedetomidine
  • Physiological Effects of Drugs
  • Hypnotics and Sedatives
  • Neurocognitive Disorders
  • Mental Disorders
  • Neurobehavioral Manifestations
  • Molecular Mechanisms of Pharmacological Action
  • Nervous System Diseases
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 60 years and 125 years
Gender
Both males and females

Description

Dexmedetomidine (DEX), a highly potent and selective ?2-adrenoceptors (?2R) agonist used in clinical practice for sedation, analgesia, and anxiolysis, was recently shown to have beneficial effects on early cognitive changes by reducing delirium in humans. It also reduced memory impairment after surg...

Dexmedetomidine (DEX), a highly potent and selective ?2-adrenoceptors (?2R) agonist used in clinical practice for sedation, analgesia, and anxiolysis, was recently shown to have beneficial effects on early cognitive changes by reducing delirium in humans. It also reduced memory impairment after surgery and isoflurane anesthesia, both in elderly mice (20-22 months) and in pups exposed to anesthesia in the early postnatal period. Importantly, co-treatment with DEX has been shown to restore learning and memory function in rats exposed to propofol in utero. Therefore, the investigators set out to investigate whether DEX has an effect on cognitive dysfunction months after surgery and whether it accelerates cognitive recovery from anesthesia and surgery. This is a multi-site trial facilitated by Clinical Trials Ontario (CTO). Participants will be randomized 1:1 in permuted blocks of 4 to 8. The randomization sequence will be computer generated and stratified by 2 factors, planned procedure (CABG/CABG + valve or valve only procedure) and study site. In hospital outcomes include delirium (assessed twice daily post-operative day (POD) 0-10, death, hemodynamic instability requiring vasopressors, time to extubation, re-intubation (and reason), length of stay (in Cardiovascular Intensive Care Unit and total hospital), POCD, depressive symptoms between POD 4-10, post-operative complications (infection [surgical site, sepsis, pneumonia], myocardial infarction, renal replacement therapy, re-operation, cumulative opioid consumption (to POD 5), in-hospital mortality. Post-operative outcomes include POCD (3/6/12 months), depression (3/6/12 months), mild cognitive impairment (MCI) at 3/6/12 months (defined as 1-2 standard deviations below age matched controls), persistent surgical site pain at sternotomy/thoracotomy/graft harvest site (Brief Pain Inventory, 3/6/12 months), recovery (3,6, 12 months).

Tracking Information

NCT #
NCT04289142
Collaborators
  • London Health Sciences Centre
  • University Health Network, Toronto
  • McMaster University
Investigators
Principal Investigator: Stephen Choi, MD,MSc,FRCPC Sunnybrook Health Sciences Centre