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, Battista Borghi, H van Oven, Andrea Tognù, L Al Tmimi, L Eyrolle, O Langeron, X Capdevila, G M ArnoldM Schaller, R Rossaint, HIPELD Study Investigators

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)127-137
Number of pages11
JournalBritish Journal of Anaesthesia
Volume120
Issue number1
DOIs
Publication statusPublished - Jan 2018

Fingerprint

Xenon
Delirium
Hip Fractures
Anesthesia
Randomized Controlled Trials
Organ Dysfunction Scores
Incidence
Controlled Clinical Trials
Least-Squares Analysis
General Anesthesia
sevoflurane

Keywords

  • aged
  • anaesthesia
  • general
  • delirium
  • hip fractures
  • xenon

Cite this

The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. / Coburn, M; Sanders, R D; Maze, M; Nguyên-Pascal, M-L; Rex, S; Garrigues, B; Carbonell, J A; Garcia-Perez, M L; Stevanovic, A; Kienbaum, P; Neukirchen, M; Schaefer, M S; Borghi, Battista; van Oven, H; Tognù, Andrea; Al Tmimi, L; Eyrolle, L; Langeron, O; Capdevila, X; Arnold, G M; Schaller, M; Rossaint, R; Study Investigators, HIPELD.

In: British Journal of Anaesthesia, Vol. 120, No. 1, 01.2018, p. 127-137.

Research output: Contribution to journalArticle

Coburn, M, Sanders, RD, Maze, M, Nguyên-Pascal, M-L, Rex, S, Garrigues, B, Carbonell, JA, Garcia-Perez, ML, Stevanovic, A, Kienbaum, P, Neukirchen, M, Schaefer, MS, Borghi, B, van Oven, H, Tognù, A, Al Tmimi, L, Eyrolle, L, Langeron, O, Capdevila, X, Arnold, GM, Schaller, M, Rossaint, R & Study Investigators, HIPELD 2018, 'The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial', British Journal of Anaesthesia, vol. 120, no. 1, pp. 127-137. https://doi.org/10.1016/j.bja.2017.11.015
Coburn, M ; Sanders, R D ; Maze, M ; Nguyên-Pascal, M-L ; Rex, S ; Garrigues, B ; Carbonell, J A ; Garcia-Perez, M L ; Stevanovic, A ; Kienbaum, P ; Neukirchen, M ; Schaefer, M S ; Borghi, Battista ; van Oven, H ; Tognù, Andrea ; Al Tmimi, L ; Eyrolle, L ; Langeron, O ; Capdevila, X ; Arnold, G M ; Schaller, M ; Rossaint, R ; Study Investigators, HIPELD. / The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. In: British Journal of Anaesthesia. 2018 ; Vol. 120, No. 1. pp. 127-137.
@article{3fc7f8e23fc24c51b7ad501cf0ab8641,
title = "The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial",
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",
author = "M Coburn and Sanders, {R D} and M Maze and M-L Nguy{\^e}n-Pascal and S Rex and B Garrigues and Carbonell, {J A} and Garcia-Perez, {M L} and A Stevanovic and P Kienbaum and M Neukirchen and Schaefer, {M S} and Battista Borghi and {van Oven}, H and Andrea Togn{\`u} and {Al Tmimi}, L and L Eyrolle and O Langeron and X Capdevila and Arnold, {G M} and M Schaller and R Rossaint and {Study Investigators}, HIPELD",
note = "Copyright {\circledC} 2017. Published by Elsevier Ltd.",
year = "2018",
month = "1",
doi = "10.1016/j.bja.2017.11.015",
language = "English",
volume = "120",
pages = "127--137",
journal = "British Journal of Anaesthesia",
issn = "0007-0912",
publisher = "Oxford University Press",
number = "1",

}

TY - JOUR

T1 - The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial

AU - Coburn, M

AU - Sanders, R D

AU - Maze, M

AU - Nguyên-Pascal, M-L

AU - Rex, S

AU - Garrigues, B

AU - Carbonell, J A

AU - Garcia-Perez, M L

AU - Stevanovic, A

AU - Kienbaum, P

AU - Neukirchen, M

AU - Schaefer, M S

AU - Borghi, Battista

AU - van Oven, H

AU - Tognù, Andrea

AU - Al Tmimi, L

AU - Eyrolle, L

AU - Langeron, O

AU - Capdevila, X

AU - Arnold, G M

AU - Schaller, M

AU - Rossaint, R

AU - Study Investigators, HIPELD

N1 - Copyright © 2017. Published by Elsevier Ltd.

PY - 2018/1

Y1 - 2018/1

N2 - 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.

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.

KW - aged

KW - anaesthesia

KW - general

KW - delirium

KW - hip fractures

KW - xenon

U2 - 10.1016/j.bja.2017.11.015

DO - 10.1016/j.bja.2017.11.015

M3 - Article

C2 - 29397119

VL - 120

SP - 127

EP - 137

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

SN - 0007-0912

IS - 1

ER -