PMID- 29397119 OWN - NLM STAT- MEDLINE DCOM- 20181221 LR - 20181221 IS - 1471-6771 (Electronic) IS - 0007-0912 (Linking) VI - 120 IP - 1 DP - 2018 Jan TI - The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. PG - 127-137 LID - S0007-0912(17)54004-0 [pii] LID - 10.1016/j.bja.2017.11.015 [doi] AB - 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. CI - Copyright (c) 2017. Published by Elsevier Ltd. FAU - Coburn, M AU - Coburn M AD - Department of Anaesthesiology, University Hospital RWTH Aachen, Pauwelsstrasse 30, D-52074 Aachen, Germany. Electronic address: mcoburn@ukaachen.de. FAU - Sanders, R D AU - Sanders RD AD - Department of Anesthesiology, Anesthesiology & Critical Care Trials & Interdisciplinary Outcome Network (ACTION), University of Wisconsin, Madison, WI, USA. FAU - Maze, M AU - Maze M AD - Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco, CA, USA. FAU - Nguyen-Pascal, M-L AU - Nguyen-Pascal ML AD - Air Liquide Sante International, Medical Research & Development, Jouy-en-Josas, France. FAU - Rex, S AU - Rex S AD - Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium. FAU - Garrigues, B AU - Garrigues B AD - Department of Anaesthesia and Surgical Intensive Care, Hospital Clinico, Universitario de Valencia, Valencia, Spain. FAU - Carbonell, J A AU - Carbonell JA AD - Department of Anaesthesia and Surgical Intensive Care, Hospital Clinico, Universitario de Valencia, Valencia, Spain. FAU - Garcia-Perez, M L AU - Garcia-Perez ML AD - Department of Anaesthesia and Surgical Intensive Care, Hospital Clinico, Universitario de Valencia, Valencia, Spain. FAU - Stevanovic, A AU - Stevanovic A AD - Department of Anaesthesiology, University Hospital RWTH Aachen, Pauwelsstrasse 30, D-52074 Aachen, Germany. FAU - Kienbaum, P AU - Kienbaum P AD - Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FAU - Neukirchen, M AU - Neukirchen M AD - Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FAU - Schaefer, M S AU - Schaefer MS AD - Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FAU - Borghi, B AU - Borghi B AD - Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy; Research Unit of Anaesthesia and Pain Therapy, Rizzoli Orthopedic Institute, Bologna, Italy. FAU - van Oven, H AU - van Oven H AD - Anesthesia and Postoperative Intensive Care, Rizzoli Orthopedic Institute, Bologna, Italy. FAU - Tognu, A AU - Tognu A AD - Anesthesia and Postoperative Intensive Care, Rizzoli Orthopedic Institute, Bologna, Italy. FAU - Al Tmimi, L AU - Al Tmimi L AD - Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium. FAU - Eyrolle, L AU - Eyrolle L AD - Department of Anaesthesia and Surgical Intensive Care, Groupe Hospitalier Cochin-Saint Vincent de Paul, Paris, France. FAU - Langeron, O AU - Langeron O AD - Department of Anaesthesia and Intensive Care, Hopital Universitaire Pitie-Salpetriere APHP, Paris, France. FAU - Capdevila, X AU - Capdevila X AD - Department of Anaesthesia, Centre Hospitalier Regional Universitaire de Montpellier, Hopital Lapeyronie, Montpellier, France. FAU - Arnold, G M AU - Arnold GM AD - Department of Anaesthesia, Imperial College NHS Trust, London, UK. FAU - Schaller, M AU - Schaller M AD - Air Liquide Sante International, Medical Research & Development, Jouy-en-Josas, France. FAU - Rossaint, R AU - Rossaint R AD - Department of Anaesthesiology, University Hospital RWTH Aachen, Pauwelsstrasse 30, D-52074 Aachen, Germany. CN - HIPELD Study Investigators LA - eng SI - ClinicalTrials.gov/NCT01199276 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20171121 PL - England TA - Br J Anaesth JT - British journal of anaesthesia JID - 0372541 RN - 0 (Anesthetics, Inhalation) RN - 38LVP0K73A (Sevoflurane) RN - 3H3U766W84 (Xenon) SB - IM MH - Aged MH - Aged, 80 and over MH - Anesthesia, Inhalation MH - *Anesthetics, Inhalation MH - Emergence Delirium/epidemiology/*psychology MH - Female MH - Hip Fractures/mortality/*surgery MH - Humans MH - Incidence MH - Male MH - Orthopedic Procedures/adverse effects/mortality MH - Prospective Studies MH - Sevoflurane MH - Treatment Outcome MH - *Xenon OTO - NOTNLM OT - aged OT - anaesthesia, general OT - delirium OT - hip fractures OT - xenon FIR - Coburn, Mark IR - Coburn M IRAD- Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany. FIR - Rossaint, Rolf IR - Rossaint R IRAD- Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany. FIR - Stevanovic, Ana IR - Stevanovic A IRAD- Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany. FIR - Stoppe, Christian IR - Stoppe C IRAD- Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany. FIR - Fahlenkamp, Astrid IR - Fahlenkamp A IRAD- Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany. FIR - Felzen, Marc IR - Felzen M IRAD- Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany. FIR - Knobe, Mathias IR - Knobe M IRAD- Department of Orthopaedic Trauma Surgery, University Hospital RWTH Aachen, Aachen, Germany. FIR - Sanders, Robert D IR - Sanders RD IRAD- Anesthesiology & Critical Care Trials & Interdisciplinary Outcome Network (ACTION), Department of Anesthesiology, University of Wisconsin, Madison, WI, USA. FIR - Maze, Mervyn IR - Maze M IRAD- Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco, CA, USA. FIR - Nguyen-Pascal, My-Lien IR - Nguyen-Pascal ML IRAD- Air Liquide Sante International, Medical Research & Development, Jouy-en-Josas, France. FIR - Schaller, Manuella IR - Schaller M IRAD- Air Liquide Sante International, Medical Research & Development, Jouy-en-Josas, France. FIR - Garrigues, Beatriz IR - Garrigues B IRAD- Department of Anaesthesia and Surgical Critical Care, Hospital Clinico Universitario deValencia, Valencia, Spain. FIR - Carbonell, Jose Antonio IR - Carbonell JA IRAD- Department of Anaesthesia and Surgical Critical Care, Hospital Clinico Universitario deValencia, Valencia, Spain. FIR - Garcia-Perez, Marisa Luisa IR - Garcia-Perez ML IRAD- Department of Anaesthesia and Surgical Critical Care, Hospital Clinico Universitario deValencia, Valencia, Spain. FIR - Belda, Francisco J IR - Belda FJ IRAD- Department of Anaesthesia and Surgical Critical Care, Hospital Clinico Universitario deValencia, Valencia, Spain. FIR - Soro, Marina IR - Soro M IRAD- Department of Anaesthesia and Surgical Critical Care, Hospital Clinico Universitario deValencia, Valencia, Spain. FIR - Ferrando, C IR - Ferrando C IRAD- Department of Anaesthesia and Surgical Critical Care, Hospital Clinico Universitario deValencia, Valencia, Spain. FIR - Leon, Irene IR - Leon I IRAD- Department of Anaesthesia and Surgical Critical Care, Hospital Clinico Universitario deValencia, Valencia, Spain. FIR - Hernadez, J IR - Hernadez J IRAD- Department of Anaesthesia and Surgical Critical Care, Hospital Clinico Universitario deValencia, Valencia, Spain. FIR - Borghi, Battista IR - Borghi B IRAD- Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy; Research Unit of Anaesthesia and Pain Therapy, Rizzoli Orthopaedic Institute, Bologna, Italy. FIR - van Oven, Hanna IR - van Oven H IRAD- Anaesthesia and Postoperative Intensive Care, Rizzoli Orthopaedic Institute, Bologna, Italy. FIR - Tognu, Andrea IR - Tognu A IRAD- Anaesthesia and Postoperative Intensive Care, Rizzoli Orthopaedic Institute, Bologna, Italy. FIR - Guglielmetti, Aurora IR - Guglielmetti A IRAD- Anaesthesia and Postoperative Intensive Care, Rizzoli Orthopaedic Institute, Bologna, Italy. FIR - Rossi, Barbara IR - Rossi B IRAD- Research Unit of Anaesthesia and Pain Therapy, Rizzoli Orthopaedic Institute, Bologna, Italy. FIR - Fini, Greta IR - Fini G IRAD- Research Unit of Anaesthesia and Pain Therapy, Rizzoli Orthopaedic Institute, Bologna, Italy. FIR - Gallerani, Pina IR - Gallerani P IRAD- Research Unit of Anaesthesia and Pain Therapy, Rizzoli Orthopaedic Institute, Bologna, Italy. FIR - Kienbaum, Peter IR - Kienbaum P IRAD- Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FIR - Neukirchen, Martin IR - Neukirchen M IRAD- Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FIR - Schaefer, Maximilian Sebastian IR - Schaefer MS IRAD- Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FIR - Bastin, Bea IR - Bastin B IRAD- Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FIR - Kuschka, Dina IR - Kuschka D IRAD- Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FIR - Eisenach, Thorsten IR - Eisenach T IRAD- Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FIR - Gaza, Nina IR - Gaza N IRAD- Department of Anaesthesia, University Hospital Dusseldorf, Dusseldorf, Germany. FIR - Rex, Steffen IR - Rex S IRAD- Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium. FIR - Al Tmimi, Layth IR - Al Tmimi L IRAD- Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium. FIR - Devroe, Sarah IR - Devroe S IRAD- Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium. FIR - de Velde, Marc Van IR - de Velde MV IRAD- Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium. FIR - Eyrolle, Luc IR - Eyrolle L IRAD- Department of Anaesthesia and Surgical Intensive Care, Groupe Hospitalier Cochin - Saint Vincent de Paul, Paris, France. FIR - Jacquinot, Patrick IR - Jacquinot P IRAD- Department of Anaesthesia and Surgical Intensive Care, Groupe Hospitalier Cochin - Saint Vincent de Paul, Paris, France. FIR - Rosencher, Nadia IR - Rosencher N IRAD- Department of Anaesthesia and Surgical Intensive Care, Groupe Hospitalier Cochin - Saint Vincent de Paul, Paris, France. FIR - Langeron, Olivier IR - Langeron O IRAD- Department of Anaesthesia and Intensive Care, Groupe Hospitalier Pitie-Salpetrieire, Universite Pierre et Marie Curie, Paris VI, France. FIR - Roche, Sabine IR - Roche S IRAD- Department of Anaesthesia and Intensive Care, Groupe Hospitalier Pitie-Salpetrieire, Universite Pierre et Marie Curie, Paris VI, France. FIR - Paries, Marie IR - Paries M IRAD- Department of Anaesthesia and Intensive Care, Groupe Hospitalier Pitie-Salpetrieire, Universite Pierre et Marie Curie, Paris VI, France. FIR - Capdevila, Xavier IR - Capdevila X IRAD- Department of Anaesthesia, Centre Hospitalier Regional Universitaire de Montpellier, Hopital Lapeyronie, Montpellier, France. FIR - Arnold, Glenn IR - Arnold G IRAD- Department of Anaesthesia, Imperial College NHS Trust, London, UK. FIR - Graham, Benjamin IR - Graham B IRAD- Department of Anaesthesia, Imperial College NHS Trust, London, UK. FIR - Doyle, Patrick IR - Doyle P IRAD- Department of Anaesthesia, Imperial College NHS Trust, London, UK. FIR - Albaladejo, P IR - Albaladejo P IRAD- Department of Anaesthesia, Centre Hospitalier et Universitaire de Grenoble, Hopital Michallon, La Tronche, France. FIR - Minville, Vincent IR - Minville V IRAD- Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier et Universitaire de Toulouse, Hopital Rangueil, Toulouse, France. FIR - Ferre, Fabrice IR - Ferre F IRAD- Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier et Universitaire de Toulouse, Hopital Rangueil, Toulouse, France. FIR - Kunitz, Oliver IR - Kunitz O IRAD- Department of Anaesthesia, Emergency and Intensive Care Medicine, Klinikum Mutterhaus der Borromaerinnen gGmbH, Trier, Germany. EDAT- 2018/02/06 06:00 MHDA- 2018/12/24 06:00 CRDT- 2018/02/05 06:00 PHST- 2017/08/22 00:00 [accepted] PHST- 2018/02/05 06:00 [entrez] PHST- 2018/02/06 06:00 [pubmed] PHST- 2018/12/24 06:00 [medline] AID - S0007-0912(17)54004-0 [pii] AID - 10.1016/j.bja.2017.11.015 [doi] PST - ppublish SO - Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.