deltatrials
Completed INTERVENTIONAL NCT03624595

Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery

Effect of Low-dose Dexmedetomidine on Postoperative Delirium in Patients After Cardiac Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial

Sponsor: Dong-Xin Wang

Updated 16 times since 2018 Last updated: Apr 22, 2026 Started: Apr 16, 2019 Primary completion: Jul 3, 2021 Completion: May 18, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Cardiac Surgery and Cardiopulmonary Bypass, this trial is completed. The trial is conducted by Dong-Xin Wang and has accumulated 16 data snapshots since 2019. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Study Description(click to expand)

Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. The development of delirium is a consequence of multiple factors. For patients undergoing cardiac surgery, surgical stress and/or cardiopulmonary bypass can produce hyper-inflammatory and stress response, both of which are important factors leading to delirium. Meanwhile, patients in ICU after major surgery often develop sleep disturbances, which are also associated with increased risk of delirium. Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anxiolytic properties. In previous studies of elderly patients admitted to ICU after non-cardiac surgery, continuous infusion of low-dose dexmedetomidine during nighttime improves sleep quality, reduces delirium, and improves 2-year survival. The investigators hypothesize that, for patients admitted to ICU after cardiac surgery, nighttime infusion of low-dose dexmedetomidine can decrease the incidence of delirium and improve long-term survival. The purpose of this study is to investigate the effect of nighttime infusion of low-dose dexmedetomidine on postoperative sleep quality, delirium, and 2-year survival in elderly patients admitted to ICU after cardiac surgery.

Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes.

The development of delirium is a consequence of multiple factors. For patients undergoing cardiac surgery, surgical stress and/or cardiopulmonary bypass can produce hyper-inflammatory and stress response, both of which are important factors leading to delirium. Meanwhile, patients in ICU after major surgery often develop sleep disturbances, which are also associated with increased risk of delirium.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anxiolytic properties. In previous studies of elderly patients admitted to ICU after non-cardiac surgery, continuous infusion of low-dose dexmedetomidine during nighttime improves sleep quality, reduces delirium, and improves 2-year survival.

The investigators hypothesize that, for patients admitted to ICU after cardiac surgery, nighttime infusion of low-dose dexmedetomidine can decrease the incidence of delirium and improve long-term survival. The purpose of this study is to investigate the effect of nighttime infusion of low-dose dexmedetomidine on postoperative sleep quality, delirium, and 2-year survival in elderly patients admitted to ICU after cardiac surgery.

Status Flow

~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Apr 2019 · 3 months · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jan 2020 · 8 months · monthly snapshot~Jan 2020 – ~Dec 2020 · 11 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Oct 2023 · 24 months · monthly snapshot~Oct 2023 – ~Jun 2024 · 8 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshot~May 2025 – ~Apr 2026 · 12 months · monthly snapshotApr 28, 2026 – present · 4 months · daily API

Change History

16 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Completed

    Status: Active Not RecruitingCompleted · Phase: NANone

  2. May 2025 — Apr 2026 [monthly]

    Active Not Recruiting NA

  3. Sep 2024 — May 2025 [monthly]

    Active Not Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  5. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting NA

    Status: Unknown StatusActive Not Recruiting

Show 11 earlier versions
  1. Oct 2023 — Jun 2024 [monthly]

    Unknown Status NA

    Status: Active Not RecruitingUnknown Status

  2. Oct 2021 — Oct 2023 [monthly]

    Active Not Recruiting NA

  3. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting · Phase: PHASE4NA

  4. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE4

  5. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE4

  6. Jan 2020 — Dec 2020 [monthly]

    Recruiting PHASE4

  7. May 2019 — Jan 2020 [monthly]

    Recruiting PHASE4

    Status: Not Yet RecruitingRecruiting

  8. Apr 2019 — May 2019 [monthly]

    Not Yet Recruiting PHASE4

  9. Jan 2019 — Apr 2019 [monthly]

    Not Yet Recruiting PHASE4

  10. Nov 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE4

  11. Sep 2018 — Nov 2018 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.

Contact Information

Sponsor contact:
  • Dong-Xin Wang
  • Fu Wai Hospital, Beijing, China
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations