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

Inclusion Criteria1

  • Patients above the age of 60 years undergoing major elective non cardiac surgery, defined as surgery expected to last at least 1 hour in duration and requiring admission to hospital.

Exclusion Criteria7

  • Participants will be ineligible to take part if they;
  • Have known contraindications to NAC including allergies and concomitant nitrate therapy
  • Are unable to comply with the requirements of informed consent or the study protocol
  • Are already taking NAC
  • Require subsequent procedures necessitating general anaesthesia prior to completion of testing procedures
  • Are undergoing carotid endarterectomy, due to the high incidence of perioperative cerebrovascular accidents
  • Experience major perioperative morbidity, or mortality, that precludes them from completing post-operative cognitive testing within the prescribed time frame.

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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 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

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ACTRN12614000411640