NCT06268080 Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery
| NCT ID | NCT06268080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Auckland City Hospital |
| Condition | Delirium, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,766 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,766 participants in total. It began in 2024-05-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Carolyn Deng
PRINCIPAL INVESTIGATOR
Auckland City Hospital, Health New Zealand
Frequently Asked Questions
Who can join the NCT06268080 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Delirium, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06268080 currently recruiting?
Yes, NCT06268080 is actively recruiting participants. Contact the research team at davinams@adhb.govt.nz for enrollment information.
Where is the NCT06268080 trial being conducted?
This trial is being conducted at Grafton, New Zealand, Auckland, New Zealand, Christchurch, New Zealand.
Who is sponsoring the NCT06268080 clinical trial?
NCT06268080 is sponsored by Auckland City Hospital. The principal investigator is Carolyn Deng at Auckland City Hospital, Health New Zealand. The trial plans to enroll 2,766 participants.