drugset / Trial / NCT06087510

Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes

NCT06087510

Phase 4 Recruiting 312 enrolled Peking University First Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2024-01-24
Primary completion
2025-12
Completion
2026-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 50 mg
Subject Esketamine Other / unclassified 100 mg
Subject Esketamine Other / unclassified 150 mg