Comparing light and deep anesthesia effects on postoperative delirium and cognition in older adults
Preserving Brain Health After Surgery: Does Light General Anesthesia Reduce Postoperative Delirium and Cognitive Decline Compared With Deep General Anesthesia in Older Adults?
This study is testing if using lighter anesthesia during major surgery can help older adults avoid confusion and memory problems afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2766 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Auckland City Hospital Government |
| Locations | 3 sites (Grafton, Auckland and 2 other locations) |
| Trial ID | NCT06268080 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 years and above, or Indigenous and Pacific patients aged 55 years, undergoing major surgery with general anesthesia.
Not a fit: Patients undergoing intracranial or cardiac surgery, or those with severe cognitive impairment unable to consent, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rates of postoperative delirium and cognitive decline in older adults, improving their recovery and quality of life.
How similar studies have performed: Previous studies have shown mixed results regarding anesthesia depth and delirium, making this approach both promising and novel in its specific focus on high-risk populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Grafton, Auckland and 2 other locations
- Auckland City Hospital, Health New Zealand — Grafton, Auckland, New Zealand (Recruiting)
- North Shore Hospital — Auckland, North Island, New Zealand (Not_yet_recruiting)
- Christchurch Hospital — Christchurch, South Island, New Zealand (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.