Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients
CODEX
1 other identifier
interventional
2,400
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2019
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
December 1, 2025
July 1, 2025
8.6 years
October 9, 2019
November 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative cognitive dysfunction
Presence of POCD assessed by CogState Brief Battery (CBB)
3 months
Secondary Outcomes (10)
Post-operative cognitive dysfunction (POCD) at 1 week, 6 months, 12 months after surgery
1 week, 6 and 12 months
Delirium
Anytime up to post-operative day 10
Length of stay
An average of 5 -14 days
Depressive symptoms
3, 6, and 12 months
Persistent Surgical Site Pain
3, 6, and 12 months
- +5 more secondary outcomes
Study Arms (2)
Dexmedetomidine Hydrochloride Group
ACTIVE COMPARATORPatients 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.
Standard of Care Group
NO INTERVENTIONStandard sedation protocols will be followed at the discretion of the attending physician.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Planned CABG (+/- valve, including off-pump) or valve replacement via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)
- Age ≥60
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- London Health Sciences Centrecollaborator
- University Health Network, Torontocollaborator
- McMaster Universitycollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
- The Dana Foundationcollaborator
- Brain Canadacollaborator
- Alzheimer's Associationcollaborator
- Hamilton Health Sciences Corporationcollaborator
- University of Saskatchewancollaborator
- Fraser Healthcollaborator
- Providence Health & Servicescollaborator
Study Sites (8)
Royal Columbian Hospital
Vancouver, British Columbia, V3L 0A2, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
London Health Sciences
London, Ontario, N6A 5A5, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Laval University
Québec, Quebec, G1V 0A6, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Publications (1)
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.
PMID: 33849856DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Choi, MD,MSc,FRCPC
Sunnybrook Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2019
First Posted
February 28, 2020
Study Start
December 1, 2019
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
December 1, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available upon request immediately after publication of the primary results. No end date.
- Access Criteria
- Direct request to PI. Anyone who wishes to access the data.
All de-identified participants data collected during this trial that underlie the results reported in the publication(s) will be available upon request after publication of the primary results.