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Randomized Controlled Trial Multicenter Study
The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial.
- M Coburn, R D Sanders, M Maze, M-L Nguyên-Pascal, S Rex, B Garrigues, J A Carbonell, M L Garcia-Perez, A Stevanovic, P Kienbaum, M Neukirchen, M S Schaefer, B Borghi, H van Oven, A Tognù, L Al Tmimi, L Eyrolle, O Langeron, X Capdevila, G M Arnold, M Schaller, R Rossaint, and HIPELD Study Investigators.
- Department of Anaesthesiology, University Hospital RWTH Aachen, Pauwelsstraße 30, D-52074 Aachen, Germany. Electronic address: mcoburn@ukaachen.de.
- Br J Anaesth. 2018 Jan 1; 120 (1): 127-137.
BackgroundPostoperative 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.MethodsThis 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).ResultsOf 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.ConclusionsXenon 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.Clinical Trial RegistrationEudraCT 2009-017153-35; ClinicalTrials.gov NCT01199276.Copyright © 2017. Published by Elsevier Ltd.
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