At a glance
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NCT06087510Phase 4RecruitingUpdate OverdueUpdated 11mo ago · Completion was 6mo agoImpact of Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia on Long-term Outcomes After Scoliosis Correction Surgery: Follow-up of a Randomized Trial
In Brief
A Phase 4 clinical trial evaluating Esketamine for Scoliosis Correction and 4 related conditions. Currently recruiting, targeting 312 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Different doses of esketamine in the esketamine-dexmedetomidine combination as a supplement to sufentanil for postoperative analgesia.