Anaesthetic depth and delirium after major surgery: a randomised clinical trial.
Lisbeth A Evered, Matthew T V Chan, Ruquan Han...
https://pubmed.ncbi.nlm.nih.gov/34465469/Actively Recruiting
Led by Auckland City Hospital · Updated on 2025-09-25
2766
Participants Needed
3
Research Sites
52 weeks
Total Duration
Researchers are studying the effects of light versus deep general anesthesia in older adults undergoing major surgery to see if lighter anesthesia can reduce postoperative delirium, cognitive decline, and disability. Delirium is a common and serious complication in older surgical patients, causing distress and long-term health issues. This trial targets older adults aged 65 and above, including Indigenous and Pacific patients aged 55 and above, undergoing non-heart and non-brain major surgery under total intravenous anesthesia TIVA. Participants will be randomly assigned to two groups receiving either light or deep general anesthesia guided by processed electroencephalography pEEG brain monitors, such as the Bispectral Index BIS or Patient State Index PSI. The anesthesiologist will adjust anesthetic drugs based on brain wave readings from 10 minutes after anesthesia induction until awakening. The study limits certain drugs that interfere with brain monitoring. Care during surgery follows standard protocols except for the anesthesia depth adjustment. During the study, participants will be assessed twice daily for up to three days after surgery to detect delirium and monitored further if delirium occurs. Longer-term follow-ups at 90 days and one year will evaluate cognitive, physical function, and survival outcomes. The study aims to understand if anesthesia depth affects delirium rates and longer-term brain health, with careful tracking of participant health and safety throughout the process.
CONDITIONS
Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery
D
Davina J McAllister, DipNursing
C
Carolyn Deng
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Auckland City Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and hospital stay of at least 2 nights
Participants undergo major surgery with general anesthesia titrated to a light or deep level using brain monitoring devices. Anesthesia is maintained from 10 minutes after induction until emergence.
Daily assessments twice a day for up to 3 days post-surgery, with additional daily testing on days 4 to 7 if delirium is detected
Duration - Up to 1 year after surgery
Participants are assessed for cognitive, functional, and delirium outcomes after surgery to monitor recovery and long-term effects.
Assessments at 90 days and 1 year after surgery
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Lisbeth A Evered, Matthew T V Chan, Ruquan Han...
https://pubmed.ncbi.nlm.nih.gov/34465469/Matthew Sumner, Carolyn Deng, Lis Evered...
https://pubmed.ncbi.nlm.nih.gov/35183345/Carolyn Deng, David Sidebotham
https://pubmed.ncbi.nlm.nih.gov/37144615/L Evered, B Silbert, D S Knopman...
https://pubmed.ncbi.nlm.nih.gov/30336844/Auckland City Hospital
Lead Sponsor