Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

  • STATUS
    Recruiting
  • End date
    Mar 26, 2026
  • participants needed
    2400
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 26 January 2021
Investigator
Stephen Choi, MD
Primary Contact
Sunnybrook Health Sciences Centre (7.2 mi away) Contact
anesthesia
dexmedetomidine
cognitive impairment
cabg
cardiac surgery
heart surgery
coronary artery bypass graft
cognitive deficits
memory impairment
cognitive disorder
thoracotomy
coma
postoperative cognitive dysfunction

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.

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 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).

Details
Condition Nervous system symptoms, Delirium, Confusion, Physiological Effects of Drugs, Molecular Mechanisms of Pharmacological Action, Central Nervous System Depressants, Mental illness, Cognitive Symptoms, Dexmedetomidine, nervous system disorder, Neurologic Disorders, Hypnotics, Non-opioid analgesics, Cognitive Disorder, Signs and Symptoms, Analgesics, Cognitive Impairment, Cognitive Dysfunction, Neurocognitive Disorders, Cognitive Deficits, Psychological Disorders, Neurocognitive Disorder, Cognitive Deficit, Cognitive Impairments, Neurologic Disorders, psychiatric disorder, psychiatric illness, mental disorder, psychiatric disorders, mental disorders, psychological disorder, psychiatric diseases, psychiatric disease, mental disease, neurological disorders, neurological disorder, neurologic disorder, disorders of the nervous system, nervous system disease, neurological disease, nervous system disorders, attention disorders, cognition disorders, cognitive disorders, disorder attention, cns depressant, neurocognitive disturbance, confused, disorientation, sedative, sedative-hypnotics, analgesic, analgesic drugs, pain medication, pain killers, analgesic agents, pain medicine, painkillers, anodyne, symptoms and signs, clinical finding
Treatment Dexmedetomidine Hydrochloride Group
Clinical Study IdentifierNCT04289142
SponsorSunnybrook Health Sciences Centre
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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)
Aortic arch replacement/re-implantation (Bentalls)
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)
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