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Randomized Controlled Trial
Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial.
- Ying Zhang, Fan Cui, Jia-Hui Ma, and Dong-Xin Wang.
- Department of Anesthesiology, Peking University First Hospital, Beijing, China.
- Br J Anaesth. 2023 Aug 1; 131 (2): 385396385-396.
BackgroundPatients often experience severe pain after scoliosis correction surgery. Esketamine and dexmedetomidine each improves analgesia but can produce side-effects. We therefore tested the hypothesis that a mini-dose esketamine-dexmedetomidine combination safely improves analgesia.MethodsTwo hundred male and female adults having scoliosis correction surgery were randomised to patient-controlled sufentanil analgesia (4 μg kg-1 in normal saline) with either a combined supplement (esketamine 0.25 mg ml-1 and dexmedetomidine 1 μg ml-1) or placebo. The primary outcome was the incidence of moderate-to-severe pain within 72 h, defined as a numeric rating scale (NRS: 0=no pain and 10=worst pain) score ≥4 at any of seven time points. Amongst secondary outcomes, subjective sleep quality was assessed with an NRS score (0=best sleep and 10=worst sleep) for the first five postoperative nights.ResultsThere were 199 subjects included in the intention-to-treat analysis. Mean infusion rates were 5.5 μg kg-1 h-1 for esketamine and 0.02 μg kg-1 h-1 for dexmedetomidine. The primary outcome incidence was lower with the combined supplement (65.7% [65/99]) than with placebo (86.0% [86/100]; relative risk 0.76; 95% confidence interval: 0.65-0.90; P=0.001). Subjects given the combined supplement had lower pain intensity at rest at five time points (median difference -1 point; P≤0.005), lower pain intensity with movement at six time points (median difference -1 point; P≤0.001), and better subjective sleep quality for the first 5 postoperative nights (median difference -2 to -1 points; P<0.001). Adverse events did not differ between groups.ConclusionsThe mini-dose esketamine-dexmedetomidine combination safely improved analgesia and subjective sleep quality after scoliosis correction surgery.Clinical Trial RegistrationNCT04791059.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
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