The Post Anaesthesia N-Acetycysteine Cognitive Evaluation trial, investigating the potential for N-Acetylcysteine to reduce cognitive dysfunction following major elective non-cardiac surgery
Randomised controlled trial of N-Acetyl-Cysteine vs placebo for the prevention of Post Operative Cognitive Dysfunction in major elective non-cardiac surgery
The Geelong Hospital
370 participants
Apr 29, 2015
Interventional
Conditions
Summary
Aims: * To examine the effectiveness of NAC in reducing POCD (primary aim) * To investigate the effectiveness of NAC in reducing biomarkers of neuroinflammation and oxidative stress in the perioperative setting * To examine the correlation between cognition and biomarkers * To identify possible predictors of POCD Hypotheses: * The administration of NAC in a perioperative setting is more effective than placebo in reducing the severity of early POCD, as measured by performance changes on a neuropsychological battery (primary hypothesis) * The administration of NAC in a perioperative setting is more effective than placebo in reducing the severity of long term POCD * The administration of NAC in a perioperative setting is more effective than placebo in reducing the incidence of post operative delirium * The administration of NAC in a perioperative setting is more effective than placebo in reducing the incidence of post operative mood disorders * The administration of NAC in a perioperative setting is more effective than placebo in improving quality of life * The administration of NAC in a perioperative setting is more effective than placebo in improving post surgical pain * The administration of NAC in a perioperative setting is more effective than placebo in reducing serum levels of biomarkers of neuroinflammation and oxidative stress
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
N-Acetyl-Cysteine 600mg oral capsules dosage regimen = 1200mg twice daily, commencing 1-2 hours prior to surgery, continuing for 4 days, with a resultant total dose of 9600mg Adherence to be monitored by trial coordinators via daily patient visits, medication chart review, and clinical effect to be correlated with biomarker evidence of antioxidant action.
Locations(1)
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ACTRN12614000411640