Department of Anaesthesiology, University Hospital RWTH Aachen, Pauwelsstraße 30, D-52074 Aachen, Germany.
Department of Anesthesiology, Anesthesiology & Critical Care Trials & Interdisciplinary Outcome Network (ACTION), University of Wisconsin, Madison, WI, USA.
Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.
Postoperative delirium occurs frequently in elderly hip fracture surgery patients and is associated with poorer overall outcomes. Because xenon anaesthesia has neuroprotective properties, we evaluated its effect on the incidence of delirium and other outcomes after hip fracture surgery.
This was a phase II, multicentre, randomized, double-blind, parallel-group, controlled clinical trial conducted in hospitals in six European countries (September 2010 to October 2014). Elderly (≥75yr-old) and mentally functional hip fracture patients were randomly assigned 1:1 to receive either xenon- or sevoflurane-based general anaesthesia during surgery. The primary outcome was postoperative delirium diagnosed through postoperative day 4. Secondary outcomes were delirium diagnosed anytime after surgery, postoperative sequential organ failure assessment (SOFA) scores, and adverse events (AEs).
Of 256 enrolled patients, 124 were treated with xenon and 132 with sevoflurane. The incidence of delirium with xenon (9.7% [95% CI: 4.5 -14.9]) or with sevoflurane (13.6% [95% CI: 7.8 -19.5]) were not significantly different (P=0.33). Overall SOFA scores were significantly lower with xenon (least-squares mean difference: -0.33 [95% CI: -0.60 to -0.06]; P=0.017). For xenon and sevoflurane, the incidence of serious AEs and fatal AEs was 8.0% vs 15.9% (P=0.05) and 0% vs 3.8% (P=0.06), respectively.
Xenon anaesthesia did not significantly reduce the incidence of postoperative delirium after hip fracture surgery. Nevertheless, exploratory observations concerning postoperative SOFA-scores, serious AEs, and deaths warrant further study of the potential benefits of xenon anaesthesia in elderly hip fracture surgery patients.
EudraCT 2009-017153-35; ClinicalTrials.gov NCT01199276.
术后谵妄在老年髋部骨折手术患者中很常见，与整体预后较差有关。由于氙气麻醉具有神经保护作用，我们评估了其对髋部骨折手术后谵妄发生率和其他结果的影响。
这是一项在欧洲六个国家的医院进行的 II 期、多中心、随机、双盲、平行组、对照临床试验（2010 年 9 月至 2014 年 10 月）。老年（≥75 岁）和精神功能正常的髋部骨折患者被随机分配 1:1 接受氙气或七氟醚全身麻醉。主要结局是术后第 4 天通过术后诊断的术后谵妄。次要结局是术后任何时候诊断的谵妄、术后序贯器官衰竭评估（SOFA）评分和不良事件（AE）。
在 256 名入组患者中，124 名接受氙气治疗，132 名接受七氟醚治疗。氙气（9.7%[95%CI：4.5-14.9%]）或七氟醚（13.6%[95%CI：7.8-19.5%]）的谵妄发生率无显著差异（P=0.33）。SOFA 评分总体较低（最小二乘均数差值：-0.33[95%CI：-0.60 至-0.06]；P=0.017）。氙气和七氟醚的严重 AE 和致命 AE 发生率分别为 8.0%和 15.9%（P=0.05）和 0%和 3.8%（P=0.06）。
髋部骨折手术后，氙气麻醉并未显著降低术后谵妄的发生率。然而，关于术后 SOFA 评分、严重 AE 和死亡的探索性观察结果表明，需要进一步研究氙气麻醉在老年髋部骨折手术患者中的潜在益处。
EudraCT 2009-017153-35；ClinicalTrials.gov NCT01199276。
