Comparing light and deep anesthesia effects on postoperative delirium and cognition in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Balanced-2 study aims to evaluate whether lighter general anesthesia can reduce the incidence of postoperative delirium and cognitive decline in older adults undergoing major surgery. This randomized controlled trial will utilize processed electroencephalography (pEEG) to titrate anesthesia depth, comparing light versus deep anesthesia. Participants will be older adults aged 65 and above, or Indigenous and Pacific patients aged 55 and above, who are at higher risk for delirium. The study will ensure adherence to the intervention and proper group separation to yield reliable results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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's running

• Auckland City Hospital, Health New Zealand
  Grafton, Auckland, New Zealand Recruiting
• Christchurch Hospital
  Christchurch, South Island, New Zealand Recruiting
• North Shore Hospital
  Auckland, North Island, New Zealand Not yet recruiting

Study contacts

• Principal investigator: Carolyn Deng — Auckland City Hospital, Health New Zealand
• Study coordinator: Davina J McAllister, DipNursing
• Email: davinams@adhb.govt.nz
• Phone: +64 274891940

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can citicoline help prevent cognitive decline after delirium in older adults with hip fracture?

  This study tests whether taking citicoline for 6 months after discharge helps prevent cognitive decline in adults 65 and older who had delirium during hospitalization for hip fracture.

  Recruiting Phase 2 University of Milano Bicocca · Monza, Monza E Brianza · NCT07804498

• VR-based cognitive games to help prevent delirium after big surgery

  A VR-based cognitive stimulation game is being tested to see if it can help prevent delirium in adults 65 and older after major surgery.

  Recruiting at 2 sites The Methodist Hospital Research Institute · Houston, Texas and 1 other locations · NCT07641153

• Personalized iPad audio messages to reduce confusion after hip fracture surgery

  This trial will try 2-minute personalized audio reorientation messages on an iPad to see if they help prevent confusion (delirium) in people aged 60 and over after hip fracture surgery.

  Recruiting Sengkang General Hospital · Singapore · NCT07396532

• Fluvoxamine to reduce delirium after non-cardiac surgery

  This study will test whether giving fluvoxamine around the time of elective non-cardiac, non-intracranial surgery can help reduce postoperative delirium in older adults who will stay in the hospital at least two days.

  Recruiting Phase 3 Washington University School of Medicine · St Louis, Missouri · NCT06969287

• Combining sleep promotion and cognitive training to improve brain function in older ICU survivors

  This study is testing if helping older adults who survived ICU treatment sleep better and do brain exercises can improve their thinking skills.

  Recruiting University of Washington · Seattle, Washington · NCT06411561

• Assessing sleep and circadian rhythms in older adults after major orthopedic surgery

  This study is testing how sleep patterns and certain biological markers in older adults after major orthopedic surgery can help us understand the risk of confusion and memory problems afterward.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT06052397

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.