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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Xenon for the prevention of postoperative delirium in cardiac surgery: study protocol for a randomized controlled clinical trial

Authors: Layth Al Tmimi, Marc Van de Velde, Paul Herijgers, Bart Meyns, Geert Meyfroidt, Koen Milisen, Steffen Fieuws, Mark Coburn, Koen Poesen, Steffen Rex

Published in: Trials | Issue 1/2015

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Abstract

Background

Postoperative delirium (POD) is a manifestation of acute postoperative brain dysfunction that is frequently observed after cardiac surgery. POD is associated with short-term complications such as an increase in mortality, morbidity, costs and length of stay, but can also have long-term sequelae, including persistent cognitive deficits, loss of independence, and increased mortality for up to 2 years. The noble gas xenon has been demonstrated in various models of neuronal injury to exhibit remarkable neuroprotective properties. We therefore hypothesize that xenon anesthesia reduces the incidence of POD in elderly patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

Methods/Design

One hundred and ninety patients, older than 65 years, and scheduled for elective cardiac surgery, will be enrolled in this prospective, randomized, controlled trial. Patients will be randomized to receive general anesthesia with either xenon or sevoflurane. Primary outcome parameter will be the incidence of POD in the first 5 postoperative days. The occurrence of POD will be assessed by trained research personnel, blinded to study group, with the validated 3-minute Diagnostic Confusion Assessment Method (3D-CAM) (on the intensive care unit in its version specifically adapted for the ICU), in addition to chart review and the results of delirium screening tools that will be performed by the bedside nurses). Secondary outcome parameters include duration and severity of POD, and postoperative cognitive function as assessed with the Mini-Mental State Examination.

Discussion

Older patients undergoing cardiac surgery are at particular risk to develop POD. Xenon provides remarkable hemodynamic stability and has been suggested in preclinical studies to exhibit neuroprotective properties. The present trial will assess whether the promising profile of xenon can be translated into a better outcome in the geriatric population.

Trial registration

EudraCT Identifier: 2014-005370-11 (13 May 2015).
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Metadata
Title
Xenon for the prevention of postoperative delirium in cardiac surgery: study protocol for a randomized controlled clinical trial
Authors
Layth Al Tmimi
Marc Van de Velde
Paul Herijgers
Bart Meyns
Geert Meyfroidt
Koen Milisen
Steffen Fieuws
Mark Coburn
Koen Poesen
Steffen Rex
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0987-4

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