Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery
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 c
| Condition(s) | Delirium, Postoperative, Anesthesia, Surgery-Complications, Cognition Disorder, Delirium, Cognitive Decline |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 yea |
| Who can participate | 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 * Clini |
| Ages | 55 Years |
| Sex | All |
| Lead sponsor | Auckland City Hospital |
| Locations | Grafton, Auckland, New Zealand; Auckland, North Island, New Zealand; Christchurch, South Island, New Zealand |
| Start date | 2024-05-20 |
| NCT ID | NCT06268080 |
| Official listing | https://clinicaltrials.gov/study/NCT06268080 |