Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery

Recruiting now · Not applicable

Conditions studied: Delirium, Postoperative, Anesthesia, Surgery-Complications, Cognition Disorder, Delirium, Cognitive Decline

In brief

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.

Key facts

Study ID

NCT06268080

Run by

Auckland City Hospital

People needed

2766

Starts

2024-05-20

Expected to finish

2028-12-31

Last updated by the study team

2025-09-25

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged ≥ 65 years, and Māori, Pacific or Indigenous participants aged ≥ 55 years who are undergoing major elective or non-elective surgery with expected surgical duration ≥ 2 hours and postoperative hospital stay ≥ 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)

You may not qualify if…

• 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

Where it is running

• Auckland City Hospital, Health New Zealand — Grafton, Auckland, New Zealand (enrolling)
• Christchurch Hospital — Christchurch, South Island, New Zealand (enrolling)
• North Shore Hospital — Auckland, North Island, New Zealand

Full record on ClinicalTrials.gov

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