MedTrace Logo

Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery

NCT06268080 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2766

Last updated 2025-09-25

No results posted yet for this study

Summary

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

  • Delirium, Postoperative
  • Anesthesia
  • Surgery-Complications
  • Cognition Disorder
  • Delirium
  • Cognitive Decline

Interventions

BEHAVIORAL

Depth of anesthesia titration using pEEG

Titration of maintenance anesthetic agent (propofol infusion)

Sponsors & Collaborators

  • Auckland City Hospital

    lead OTHER_GOV

Principal Investigators

  • Carolyn Deng · Auckland City Hospital, Health New Zealand

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268080 on ClinicalTrials.gov