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, HIPELD Study Investigators, Mark Coburn, Rolf Rossaint, Ana Stevanovic, Christian Stoppe, Astrid Fahlenkamp, Marc Felzen, Mathias Knobe, Robert D Sanders, Mervyn Maze, My-Liên Nguyên-Pascal, Manuella Schaller, Beatriz Garrigues, José Antonio Carbonell, Marisa Luisa Garcia-Perez, Francisco J Belda, Marina Soro, C Ferrando, Irene León, J Hernadez, Battista Borghi, Hanna van Oven, Andrea Tognù, Aurora Guglielmetti, Barbara Rossi, Greta Fini, Pina Gallerani, Peter Kienbaum, Martin Neukirchen, Maximilian Sebastian Schaefer, Bea Bastin, Dina Kuschka, Thorsten Eisenach, Nina Gaza, Steffen Rex, Layth Al Tmimi, Sarah Devroe, Marc Van de Velde, Luc Eyrolle, Patrick Jacquinot, Nadia Rosencher, Olivier Langeron, Sabine Roche, Marie Paries, Xavier Capdevila, Glenn Arnold, Benjamin Graham, Patrick Doyle, P Albaladejo, Vincent Minville, Fabrice Ferré, Oliver Kunitz, 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, HIPELD Study Investigators, Mark Coburn, Rolf Rossaint, Ana Stevanovic, Christian Stoppe, Astrid Fahlenkamp, Marc Felzen, Mathias Knobe, Robert D Sanders, Mervyn Maze, My-Liên Nguyên-Pascal, Manuella Schaller, Beatriz Garrigues, José Antonio Carbonell, Marisa Luisa Garcia-Perez, Francisco J Belda, Marina Soro, C Ferrando, Irene León, J Hernadez, Battista Borghi, Hanna van Oven, Andrea Tognù, Aurora Guglielmetti, Barbara Rossi, Greta Fini, Pina Gallerani, Peter Kienbaum, Martin Neukirchen, Maximilian Sebastian Schaefer, Bea Bastin, Dina Kuschka, Thorsten Eisenach, Nina Gaza, Steffen Rex, Layth Al Tmimi, Sarah Devroe, Marc Van de Velde, Luc Eyrolle, Patrick Jacquinot, Nadia Rosencher, Olivier Langeron, Sabine Roche, Marie Paries, Xavier Capdevila, Glenn Arnold, Benjamin Graham, Patrick Doyle, P Albaladejo, Vincent Minville, Fabrice Ferré, Oliver Kunitz
Abstract
Background: 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.
Methods: 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).
Results: 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.
Conclusions: 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.
Clinical trial registration: EudraCT 2009-017153-35; ClinicalTrials.gov NCT01199276.
Keywords: aged; anaesthesia, general; delirium; hip fractures; xenon.
Copyright © 2017. Published by Elsevier Ltd.
Source: PubMed