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New treatment option for Delirium, Postoperative
Official title Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery
ClinicalTrials.gov ID: NCT06268080
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Patients aged ≥ 65 years, and Māori, Pacific or Indigenous participants aged ≥ 55 years who are undergoing major elective or non-elective surgery...
- Having general anesthesia using total intravenous anesthesia (TIVA) with pEEG monitoring
- Able to provide informed consent (including patients with mild preoperative neurocognitive disorders)
You likely can't join if
- 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
See the full eligibility 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...
- Having general anesthesia using total intravenous anesthesia (TIVA) with pEEG monitoring
- Able to provide informed consent (including patients with mild preoperative neurocognitive disorders)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Grafton, Auckland, New Zealand
- Auckland, North Island, New Zealand
- Christchurch, South Island, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grafton, Auckland, New Zealand; Auckland, North Island, New Zealand; Christchurch, South Island, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.