protocolSection identificationModule nctId: NCT06268080, orgStudyIdInfo id: A+9317, briefTitle: Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery, acronym: Balanced-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Auckland City Hospital, class: OTHER_GOV, descriptionModule briefSummary: 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, Pasific 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., conditionsModule conditions: Delirium, Postoperative, conditions: Anesthesia, conditions: Surgery-Complications, conditions: Cognition Disorder, conditions: Delirium, conditions: Cognitive Decline, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentre, prospective, randomized, active control, parallel group, intention to treat, safety and efficacy study., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Blinding of procedural anesthesiologist is not possible. Patients, surgeons, and all outcome assessors will be blinded. One unblinded research coordinator at each site will collect pEEG related data points. Other research coordinators will be blinded as to treatment allocation and will collect data relating to primary and secondary outcomes. Clinicians carrying out participant usual care will be able to unblind study allocation if necessary by viewing the patients anesthesia record via password protected, accessing clinician identity logged, Electronic Health Record (EHR). This record will be unavailable for access by other means., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2766, type: ESTIMATED, armsInterventionsModule interventions name: Depth of anesthesia titration using pEEG, outcomesModule primaryOutcomes measure: Incidence of postoperative delirium (POD), secondaryOutcomes measure: Incidence of severe delirium, secondaryOutcomes measure: Incidence of new mild and major postoperative neurocognitive disorders, secondaryOutcomes measure: Postoperative cognitive decline, secondaryOutcomes measure: Functional decline, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Duration of delirium, otherOutcomes measure: Incidence of awareness, otherOutcomes measure: Adverse and serious adverse events, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False