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Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Start date: Jul 1, 2023 to Mar 1, 2024
    • Eligibility criteria revised
    v11
  2. Primary and study completion dates: Dec 2025 to Dec 2026
    • Start date: Mar 10, 2022 to Jul 1, 2023
    v10
  3. Secondary endpoints: details revised at 1 of 7 entriesv9
  4. Enrollment target: 380 to 368v8 Show 8 more changesShow less
    • Primary completion date: Feb 2026 to Dec 2025
    • Study completion date: Dec 2026 to Dec 2025
    • Start date changed from estimate of Feb 2023 to Mar 10, 2022
    • Interventions: Dexmedetomidine prolonged group (Drug), Placebo group (Drug) to 0.9% saline (Drug), Dexmedetomidine prolonged sedation (Drug)
    • Secondary endpoints revised (7)
    • Study site revised
    • Study description expanded, about 5 words
    • Study title expanded, about 2 words
  5. Primary completion date: Dec 2024 to Feb 2026
    • Start date: Jul 1, 2022 to Feb 2023
    • Study completion date: Dec 2025 to Dec 2026
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Jun 1, 2022 to Dec 2024
    • Start date: Oct 1, 2021 to Jul 1, 2022
    • Study completion date: Dec 31, 2023 to Dec 2025
    v6
  2. Secondary endpoints: 5 to 7v5
  3. Primary endpoint revised
    • Secondary endpoints: 8 to 5
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Start date: Jun 1, 2021 to Oct 1, 2021
    • Secondary endpoints: details revised at 1 of 8 entries
    • Eligibility criteria expanded, about 3 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.
Trial Details
NCT Number NCT04916197
Lead Sponsor Beijing Chao Yang Hospital
Conditions
(from sponsor)		 Acute Ischemic Stroke
Related terms Ischemic Stroke
Enrollment 368 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov