Preserving Brain Health After Surgery: Does Light General Anesthesia Reduce Postoperative Delirium and Cognitive Decline Compared With Deep General Anesthesia in Older Adults?

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
New Zealand
North Shore Hospital
NOT_YET_RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Auckland City Hospital, Health New Zealand
RECRUITING
Grafton
Contact Information
Primary
Davina J McAllister, DipNursing
davinams@adhb.govt.nz
+64 274891940
Backup
Carolyn Deng
carolynd@adhb.govt.nz
+64 21666294
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 2766
Treatments
Experimental: Light general anesthesia
Bispectral Index (BIS) of 55
Active_comparator: Deep general anesthesia
Bispectral Index (BIS) of 40
Related Therapeutic Areas
Sponsors
Leads: Auckland City Hospital

This content was sourced from clinicaltrials.gov