The BALANCED Anaesthesia Study: A prospective, randomised clinical trial of two levels of anaesthetic depth on patient outcome after major surgery
Completed
- Conditions
- Complications of anaesthesiaperioperative complications10043413
- Registration Number
- NL-OMON43559
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
*60 years
ASA physical status 3 or 4
Surgery lasting *2 hours
Post-op hospital stay *2 nights
General anaesthesia with or without major regional block
Able to monitor BIS
Exclusion Criteria
Unable to monitor BIS (e.g. cranial or intracranial surgery)
Unable to consent
Surgery with *wake-up* test
Propofol infusion for part or all of maintenance of anaesthesia (*total intravenous anaesthesia*), Previous enrolment in Balanced study
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary hypothesis<br /><br>Light general anaesthesia (BIS = 50) is associated with decreased all cause<br /><br>mortality compared with deep general anaesthesia (BIS = 35) one year after<br /><br>major surgery in elderly patients.</p><br>
- Secondary Outcome Measures
Name Time Method