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Dexmedetomidine-esketamine and tDCS for Prevention of Neurocognitive Complications After Surgery

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2029 → Dec 2029
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Peking University First Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 8 more changesShow less
    • Enrollment increased: 1160 → 1996 participants
    • Start date: Jun 2026 to Oct 2026
    • Primary completion pushed from Jun 2029 to Dec 2029
    • Study completion pushed from Jun 2030 to Dec 2030
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (2)
    • Collaborators revised (5)
    • Publications: details revised at 82 of 84 entries
  2. Re-verified, no change to tracked fieldsv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Neurocognitive complications, mainly delirium and neurocognitive disorders, are common cerebral complications in older patients after surgery and associated with worse outcomes. In previous studies, perioperative use of dexmedetomidine-esketamine combination improved analgesia and sleep quality after surgery. Perioperative use of transcranial direct current stimulation (tDCS) also improved sleep quality and reduced delirium occurrence early after surgery. This 2×2 factorial trial is designed to investigate the effects of perioperative dexmedetomidine-esketamine combination and tDCS on delirium occurrence and early postoperative neurocognitive recovery in older patients.
Trial Details
NCT Number NCT07576517
Lead Sponsor Peking University First Hospital
Collaborators: Peking University Shenzhen Hospital, The First Affiliated Hospital of Air Force Medicial University, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Fujian Medical University Union Hospital
Conditions
(from sponsor)		 Older Patients, Surgery, Dexmedetomidine, Esketamine, Transcranial Direct Current Stimulation, Perioperative Neurocognitive Disorders
Enrollment 1,996 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov