NCT04289142 Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients
| NCT ID | NCT04289142 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2019-12-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,400 participants in total. It began in 2019-12-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Stephen Choi, MD,MSc,FRCPC
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT04289142 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04289142 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04289142 currently recruiting?
Yes, NCT04289142 is actively recruiting participants. Contact the research team at stephen.choi@sunnybrook.ca for enrollment information.
Where is the NCT04289142 trial being conducted?
This trial is being conducted at Vancouver, Canada, Vancouver, Canada, London, Canada, Toronto, Canada and 4 additional locations.
Who is sponsoring the NCT04289142 clinical trial?
NCT04289142 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Stephen Choi, MD,MSc,FRCPC at Sunnybrook Health Sciences Centre. The trial plans to enroll 2,400 participants.