Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
NCT06268080

Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery

Led by Auckland City Hospital · Updated on 2025-09-25

2766

Participants Needed

3

Research Sites

240 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery. Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time. Older adults (aged ≥65 years, or Indigenous, Pacific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured. If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars.

CONDITIONS

Official Title

Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery

Who Can Participate

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged �3E= 65 years, and M01ori, Pacific or Indigenous participants aged �3E= 55 years who are undergoing major elective or non-elective surgery with expected surgical duration �3E= 2 hours and postoperative hospital stay �3E= 2 nights
  • Having general anesthesia using total intravenous anesthesia (TIVA) with pEEG monitoring
  • Able to provide informed consent (including patients with mild preoperative neurocognitive disorders)
Not Eligible

You will not qualify if you...

  • Intracranial or cardiac surgery
  • Undergoing surgery with 'wake up' test
  • Previous enrollment in Balanced-2 study
  • Terminal illness with expected survival <3 months
  • Emergency surgery within 6 hours of presentation to hospital
  • Cognitive impairment with no capacity to consent or activated enduring power of attorney
  • Clinically impaired and unable to consent due to acute pathology or preoperative delirium

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Auckland City Hospital, Health New Zealand

Grafton, Auckland, New Zealand, 1024

Actively Recruiting

2

North Shore Hospital

Auckland, North Island, New Zealand, 0622

Not Yet Recruiting

3

Christchurch Hospital

Christchurch, South Island, New Zealand, 4710

Actively Recruiting

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Research Team

D

Davina J McAllister, DipNursing

CONTACT

C

Carolyn Deng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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