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Dexmedetomidine to Reduce the Incidence of POCD After Open Cardiac Surgery

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 24, 2024 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date: Jul 2024 to Jul 2026
    • Study completion date: Dec 2024 to Dec 2026
    v11
  2. Minor Re-verified, no change to tracked fieldsv10
  3. Notable Primary completion date: Jul 2022 to Jul 2024
    • Study completion date: Dec 2022 to Dec 2024
    v9
  4. Notable Primary completion date: Jul 2021 to Jul 2022
    • Study completion date: Dec 2021 to Dec 2022
    v8
  5. Notable Enrollment target: 550 to 90
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary completion date: Jul 2020 to Jul 2021
    • Study completion date: Dec 2020 to Dec 2021
    v6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Enrollment target: 90 to 550v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2018 to Aug 9, 2018
    • Site details revised
    v3
  5. Minor Study description shortened, about 25 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03480061
Lead Sponsor Sunnybrook Health Sciences Centre
Conditions
(from sponsor)
Delirium, Postoperative Cognitive Dysfunction, Dexmedetomidine, Cognitive Impairment, Depression
Related terms Cognitive Dysfunction, Delirium, Depression, Postoperative Cognitive Complications
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov