RecruitingPhase 2ACTRN12614000411640

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


Sponsor

The Geelong Hospital

Enrollment

370 participants

Start Date

Apr 29, 2015

Study Type

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

Sex: Both males and femalesMin Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement called N-Acetylcysteine (NAC), given around the time of major surgery, can reduce thinking and memory problems that sometimes occur after operations in older people (called post-operative cognitive dysfunction, or POCD). POCD can affect a person's memory and concentration for weeks or months after surgery. You may be eligible if: - You are 60 years of age or older - You are scheduled for a major elective (planned) non-cardiac surgery expected to last at least 1 hour and requiring a hospital stay You may NOT be eligible if: - You have a known allergy to NAC or are taking nitrate medications - You are unable to give informed consent or follow the study protocol - You are already taking NAC - You need another surgery under general anaesthesia before the study tests are completed - You are having a carotid endarterectomy (surgery on the neck artery) - You experience major health complications during or after surgery that prevent cognitive testing Talk to your doctor about whether this trial might be right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

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 monito

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)

Barwon Health - Geelong Hospital campus - Geelong

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614000411640