MedPath

The Post Anaesthesia N-Acetycysteine Cognitive Evaluation trial, investigating the potential for N-Acetylcysteine to reduce cognitive dysfunction following major elective non-cardiac surgery

Phase 2
Recruiting
Conditions
Post surgical pain
Mental Health - Studies of normal psychology, cognitive function and behaviour
Post Operative Cognitive Dysfunction
Surgical Stress Response
Post Operative Mood Disorder
Anaesthesiology - Anaesthetics
Surgery - Other surgery
Registration Number
ACTRN12614000411640
Lead Sponsor
The Geelong Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
370
Inclusion Criteria

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 Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
A between-groups difference in the severity of early Post-operative Cognitive Dysfunction (POCD) as measured by the psychomotor-attention composite score of the CogState Brief Battery, adjusted for baseline values. [Post Operative Day 7]
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath