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Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2025 to Mar 18, 2025
    • Site details revised
    v4
  2. Secondary endpoints: details revised at 2 of 5 entries
    • Study description revised
    • Publications: 15 to 17
    • Eligibility criteria shortened, about 1 word
    v3
  3. Primary completion date: Nov 1, 2026 to Nov 2026v2 Show 8 more changesShow less
    • Study completion date: Dec 1, 2026 to Dec 2026
    • Start date: Mar 20, 2025 to Mar 2025
    • Interventions: Dexmedetomidine-esketamine (Drug), Placebo (Drug) to Dexmedetomidine-esketamine combination (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 9 words
    • Site contact updated
    • Study title shortened, about 11 words
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery. The purpose of this trial is to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.
Trial Details
NCT Number NCT06859892
Lead Sponsor Peking University First Hospital
Conditions
(from sponsor)		 Adults, Major Noncardiac Surgery, Dexmedetomidine, Esketamine, Postoperative Sleep Disturbances
Enrollment 476 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov