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The Post-Anaesthesia N-acetylcysteine Cognitive Evaluation (PANACEA) trial: study protocol for a randomised controlled trial

Skvarc, David, Dean, Olivia, Byrne, Linda, Gray, Laura, Ives, Kathryn, Lane, Stephen, Lewis, Matthew, Osborne, Cameron, Page, Richard, Stupart, Douglas, Turner, Alyna, Berk, Michael and Marriott, Andrew 2016, The Post-Anaesthesia N-acetylcysteine Cognitive Evaluation (PANACEA) trial: study protocol for a randomised controlled trial, Trials, vol. 17, Article number: 395, pp. 1-11, doi: 10.1186/s13063-016-1529-4.

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Title The Post-Anaesthesia N-acetylcysteine Cognitive Evaluation (PANACEA) trial: study protocol for a randomised controlled trial
Author(s) Skvarc, DavidORCID iD for Skvarc, David orcid.org/0000-0002-3334-4980
Dean, OliviaORCID iD for Dean, Olivia orcid.org/0000-0002-2776-3935
Byrne, LindaORCID iD for Byrne, Linda orcid.org/0000-0001-9055-0046
Gray, LauraORCID iD for Gray, Laura orcid.org/0000-0002-7903-5796
Ives, Kathryn
Lane, Stephen
Lewis, Matthew
Osborne, Cameron
Page, RichardORCID iD for Page, Richard orcid.org/0000-0002-2225-7144
Stupart, Douglas
Turner, AlynaORCID iD for Turner, Alyna orcid.org/0000-0001-7389-2546
Berk, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Marriott, Andrew
Journal name Trials
Volume number 17
Season Article number: 395
Start page 1
End page 11
Total pages 11
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2016-08-09
ISSN 1745-6215
Keyword(s) anaesthesia and cognitive deficit
cognitive dysfunction
anaesthetics
surgery
oxidative stress
N-acetylcysteine
antioxidant
surgical stress response
delirium
dementia
Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Summary BACKGROUND: Some degree of cognitive decline after surgery occurs in as many as one quarter of elderly surgical patients, and this decline is associated with increased morbidity and mortality. Cognition may be affected across a range of domains, including memory, psychomotor skills, and executive function. Whilst the exact mechanisms of cognitive change after surgery are not precisely known, oxidative stress and subsequent neuroinflammation have been implicated. N-acetylcysteine (NAC) acts via multiple interrelated mechanisms to influence oxidative homeostasis, neuronal transmission, and inflammation. NAC has been shown to reduce oxidative stress and inflammation in both human and animal models. There is clinical evidence to suggest that NAC may be beneficial in preventing the cognitive decline associated with both acute physiological insults and dementia-related disorders. To date, no trials have examined perioperative NAC as a potential moderator of postoperative cognitive changes in the noncardiac surgery setting.

METHODS AND DESIGN: This is a single-centre, randomised, double-blind, placebo-controlled clinical trial, with a between-group, repeated-measures, longitudinal design. The study will recruit 370 noncardiac surgical patients at the University Hospital Geelong, aged 60 years or older. Participants are randomly assigned to receive either NAC or placebo (1:1 ratio), and groups are stratified by age and surgery type. Participants undergo a series of neuropsychological tests prior to surgery, 7 days, 3 months, and 12 months post surgery. It is hypothesised that the perioperative administration of NAC will reduce the degree of postoperative cognitive changes at early and long-term follow-up, as measured by changes on individual measures of the neurocognitive battery, when compared with placebo. Serum samples are taken on the day of surgery and on day 2 post surgery to quantitate any changes in levels of biomarkers of inflammation and oxidative stress.

DISCUSSION: The PANACEA trial aims to examine the potential efficacy of perioperative NAC to reduce the severity of postoperative cognitive dysfunction in an elderly, noncardiac surgery population. This is an entirely novel approach to the prevention of postoperative cognitive dysfunction and will have high impact and translatable outcomes if NAC is found to be beneficial.
Language eng
DOI 10.1186/s13063-016-1529-4
Field of Research 170101 Biological Psychology (Neuropsychology, Psychopharmacology, Physiological Psychology)
170102 Developmental Psychology and Ageing
170110 Psychological Methodology, Design and Analysis
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Socio Economic Objective 920410 Mental Health
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2016, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30085775

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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.