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Usually, infusions last between one and two hours
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Aims Primary To investigate the effectiveness of NAC in reducing the severity of cognitive decline following major elective noncardiac surgery Secondary To investigate the effectiveness of NAC in reducing biomarkers of inflammation and oxidative stress in the perioperative setting To examine correlations between changes in cognition and biomarkers To identify potential predictors of cognitive change following surgery Hypotheses Primary That administration of NAC in the perioperative setting is superior to placebo for reducing the severity of early POCD, as measured by changes in performance on the psychomotor-attention composite of the CogState Brief Battery (CBB) Secondary That administration of NAC in the perioperative setting is superior to placebo for reducing the severity of enduring cognitive change in the late postoperative period, as measured by changes in performance on the psychomotor-attention composite of the CBB 3 months post surgery, and 1 year post surgery That administration of NAC in the perioperative setting is superior to placebo for reducing the severity of cognitive change in the early postoperative period, as measured by changes on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Controlled Oral Word Association Test (COWAT), and Trail Making Tests A and B (TMT) 7 days post surgery That administration of NAC in the perioperative setting is superior to placebo for reducing the severity of cognitive change in the late postoperative period, as measured by changes on the RBANS, COWAT, and TMT at 3 months post surgery, and 1 year post surgery That administration of NAC in the perioperative setting is superior to placebo for reducing serum levels of biomarkers of inflammation and oxidative stress in the postoperative phase That there is an inverse correlation between performance on the neuropsychological battery and serum biomarkers of oxidative stress, at baseline, in the postoperative period and at follow-up Methods and design A single-centre, randomised, double-blind, placebo-controlled clinical trial
