M Coburn1, R D Sanders2, M Maze3, M-L Nguyên-Pascal4, S Rex5, B Garrigues6, J A Carbonell6, M L Garcia-Perez6, A Stevanovic7, P Kienbaum8, M Neukirchen8, M S Schaefer8, B Borghi9, H van Oven10, A Tognù10, L Al Tmimi5, L Eyrolle11, O Langeron12, X Capdevila13, G M Arnold14, M Schaller4, R Rossaint7. 1. Department of Anaesthesiology, University Hospital RWTH Aachen, Pauwelsstraße 30, D-52074 Aachen, Germany. Electronic address: mcoburn@ukaachen.de. 2. Department of Anesthesiology, Anesthesiology & Critical Care Trials & Interdisciplinary Outcome Network (ACTION), University of Wisconsin, Madison, WI, USA. 3. Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco, CA, USA. 4. Air Liquide Santé International, Medical Research & Development, Jouy-en-Josas, France. 5. Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium. 6. Department of Anaesthesia and Surgical Intensive Care, Hospital Clínico, Universitario de Valencia, Valencia, Spain. 7. Department of Anaesthesiology, University Hospital RWTH Aachen, Pauwelsstraße 30, D-52074 Aachen, Germany. 8. Department of Anaesthesia, University Hospital Düsseldorf, Düsseldorf, Germany. 9. Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy; Research Unit of Anaesthesia and Pain Therapy, Rizzoli Orthopedic Institute, Bologna, Italy. 10. Anesthesia and Postoperative Intensive Care, Rizzoli Orthopedic Institute, Bologna, Italy. 11. Department of Anaesthesia and Surgical Intensive Care, Groupe Hospitalier Cochin-Saint Vincent de Paul, Paris, France. 12. Department of Anaesthesia and Intensive Care, Hôpital Universitaire Pitié-Salpêtrière APHP, Paris, France. 13. Department of Anaesthesia, Centre Hospitalier Régional Universitaire de Montpellier, Hôpital Lapeyronie, Montpellier, France. 14. Department of Anaesthesia, Imperial College NHS Trust, London, UK.
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 withsevoflurane. 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 deliriumafter 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.
RCT Entities:
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 fracturepatients 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.
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