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Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated July 30, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Mar 2026 to Dec 2025
    • Study completion date: Dec 2026 to Sep 2026
    • Start date changed from estimate of Jan 2024 to Jan 24, 2024
    • Site details revised
  2. Secondary endpoints: details revised at 1 of 7 entries
    • Study description revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Chronic postsurgical pain (CPSP) refers to pain that occurs or increases after surgery and lasts longer than 3 months. Severe acute postoperative pain is one of the major risk factors of CPSP. Spinal correction surgery is associated with severe pain due to large trauma and long duration. Ketamine and esketamine are N-methyl-D-aspartate receptor antagonists; they have antihyperalgesic effects and may reduce CPSP. Dexmedetomidine is an alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effect; it is frequently used as an adjuvant to postoperative analgesia. In a previous trial of 200 patients after scoliosis correction surgery, mini-dose esketamine-dexmedetomidine in combination with opioids significantly improved analgesia and sleep quality but did not reduce CPSP. The authors speculate that increasing esketamine dose in the combination may further improve analgesia and, therefore, reduce the occurrence of CPSP.
Trial Details
NCT Number NCT06087510
Lead Sponsor Peking University First Hospital
Conditions
(from sponsor)		 Scoliosis Correction, Postoperative Analgesia, Esketamine, Dexmedetomidine, Chronic Postsurgical Pain
Related terms Postoperative Pain
Enrollment 312 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov