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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06268080




Registration number
NCT06268080
Ethics application status
Date submitted
13/02/2024
Date registered
20/02/2024
Date last updated
24/09/2024

Titles & IDs
Public title
Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery
Scientific title
Preserving Brain Health After Surgery: Does Light General Anesthesia Reduce Postoperative Delirium and Cognitive Decline Compared with Deep General Anesthesia in Older Adults?
Secondary ID [1] 0 0
A+9317
Universal Trial Number (UTN)
Trial acronym
Balanced-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium, Postoperative 0 0
Anesthesia 0 0
Surgery-Complications 0 0
Cognition Disorder 0 0
Delirium 0 0
Cognitive Decline 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Psychosis and personality disorders
Mental Health 0 0 0 0
Learning disabilities
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Depth of anesthesia titration using pEEG

Experimental: Light general anesthesia - Bispectral Index (BIS) of 55

Active comparator: Deep general anesthesia - Bispectral Index (BIS) of 40


BEHAVIORAL: Depth of anesthesia titration using pEEG
Titration of maintenance anesthetic agent (propofol infusion)
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of postoperative delirium (POD)
Timepoint [1] 0 0
Administered twice a daily for up to 3 postoperative days or until discharge if discharge occurs before day 3, including weekends. Further once daily testing from days 4 to 7 if screens positive.
Secondary outcome [1] 0 0
Incidence of severe delirium
Timepoint [1] 0 0
7 days after surgery
Secondary outcome [2] 0 0
Incidence of new mild and major postoperative neurocognitive disorders
Timepoint [2] 0 0
Assessed at 90 days and 1 year after surgery
Secondary outcome [3] 0 0
Postoperative cognitive decline
Timepoint [3] 0 0
Assessed at 90 days and 1 year after surgery
Secondary outcome [4] 0 0
Functional decline
Timepoint [4] 0 0
Assessed at 90 days and 1 year after surgery
Secondary outcome [5] 0 0
All-cause mortality
Timepoint [5] 0 0
Assessed at 1 year after surgery
Secondary outcome [6] 0 0
Duration of delirium
Timepoint [6] 0 0
7 days after surgery

Eligibility
Key inclusion criteria
* Patients aged = 65 years, and Maori, 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)
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
2766
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Government body
Name
Auckland City Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06268080
Trial related presentations / publications
Evered LA, Chan MTV, Han R, Chu MHM, Cheng BP, Scott DA, Pryor KO, Sessler DI, Veselis R, Frampton C, Sumner M, Ayeni A, Myles PS, Campbell D, Leslie K, Short TG. Anaesthetic depth and delirium after major surgery: a randomised clinical trial. Br J Anaesth. 2021 Nov;127(5):704-712. doi: 10.1016/j.bja.2021.07.021. Epub 2021 Aug 28.
Sumner M, Deng C, Evered L, Frampton C, Leslie K, Short T, Campbell D. Processed electroencephalography-guided general anaesthesia to reduce postoperative delirium: a systematic review and meta-analysis. Br J Anaesth. 2023 Feb;130(2):e243-e253. doi: 10.1016/j.bja.2022.01.006. Epub 2022 Feb 17.
Deng C, Sidebotham D. Using the Delphi process to determine the minimum clinically important effect size for the Balanced-2 randomised controlled trial. Clin Trials. 2023 Oct;20(5):473-478. doi: 10.1177/17407745231173058. Epub 2023 May 5.
Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
Public notes

Contacts
Principal investigator
Name 0 0
Carolyn Deng
Address 0 0
Auckland City Hospital, Health New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Davina J McAllister, DipNursing
Address 0 0
Country 0 0
Phone 0 0
+64 274891940
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06268080