Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients
NCT ID: NCT04289142
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
2400 participants
INTERVENTIONAL
2019-12-01
2029-03-31
Brief Summary
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Detailed Description
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This is a double blinded, 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
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.
Standard of Care Group
Standard sedation protocols will be followed at the discretion of the attending physician.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥60
Exclusion Criteria
* 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)
60 Years
ALL
No
Sponsors
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London Health Sciences Centre
OTHER
University Health Network, Toronto
OTHER
McMaster University
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
The Dana Foundation
OTHER
Brain Canada
OTHER
Alzheimer's Association
OTHER
Hamilton Health Sciences Corporation
OTHER
University of Saskatchewan
OTHER
Fraser Health
OTHER
Providence Health & Services
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Stephen Choi, MD,MSc,FRCPC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Royal Columbian Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
London Health Sciences
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Laval University
Québec, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Choi S, Jerath A, Jones P, Avramescu S, Djaiani G, Syed S, Saha T, Kaustov L, Kiss A, D'Aragon F, Hedlin P, Rajamohan R, Couture EJ, Singh A, Mapplebeck JC, Wong S, Orser BA. Cognitive Outcomes after DEXmedetomidine sedation in cardiac surgery: CODEX randomised controlled trial protocol. BMJ Open. 2021 Apr 13;11(4):e046851. doi: 10.1136/bmjopen-2020-046851.
Other Identifiers
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1743
Identifier Type: -
Identifier Source: org_study_id
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