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The Influence of Anaesthetic Depth on Patient Outcome after Major Surgery

A prospective, randomised, double-blind, active control, parallel assessment, intention to treat, safety and efficacy study comparing "light" and "deep" general anesthesia monitored with Bispectral Index (BIS) to investigate whether depth of anesthesia alters peri-operative outcomes in patients having major surgery

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000632897
Acronym
BALANCED
Enrollment
6649
Registered
2012-06-13
Start date
2012-12-19
Completion date
2017-12-12
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Approximately 450,000 people undergo surgery for various reasons in New Zealand. Most of these people are given general anaesthesia for their procedure. We use a range of monitoring to assess vital signs and other safety factors. One of the monitoring systems we use is the Bi-spectral Index (BIS), which uses electroencephalogram (EEG) waves to determine the depth (how deeply anaesthetised) patients are during their procedure. These monitoring systems are widely available nationally and internationally, however, the optimal depth at which anaesthetics should be given is unknown. Recent observational studies have shown a 20% increase in mortality in patients undergoing major surgery who receive relatively deep anaesthesia. We plan to perform a large scale randomized trial investigating the difference between two clinically standard depth ranges, which are commonly referred to “light” and “deep” anaesthesia, to definitively answer the question of whether anaesthetic depth alters surgical outcome. In particular we will look at death rate at one year and also whether there are differences in other complications of surgery and anaesthesia, including wound infection, cardiovascular and neurological complications, pain and awareness

Interventions

General anaesthesia monitored with Bispectral Index (BIS). BIS targets will be either 50 or 35. We expect 90% of anaesthesia time to be within 5 units of the target range and no deviations for >5 minutes. Anaesthesia standard care using standard anaesthetic hypnotics, volatiles, opioids and relaxants, intravenous or inhalational gas induction, volatile maintenance, continuous BIS monitoring, computerised data logging of BIS, blood pressure and volatile anaesthetic concentration. An individualise

General anaesthesia monitored with Bispectral Index (BIS). BIS targets will be either 50 or 35. We expect 90% of anaesthesia time to be within 5 units of the target range and no deviations for >5 minutes. Anaesthesia standard care using standard anaesthetic hypnotics, volatiles, opioids and relaxants, intravenous or inhalational gas induction, volatile maintenance, continuous BIS monitoring, computerised data logging of BIS, blood pressure and volatile anaesthetic concentration. An individualised blood pressure target range appropriate for the patient being studied will be set by the anaesthetist before BIS target randomization

Sponsors

Assoc Professor Dr Timothy Short
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age equal to/greater than 60 years, ASA grade 3 or 4, surgery expected to last >2 hours, post-operative hospital stay expected to be 2 or more nights, general anaesthesia with or without major regional block.

Exclusion criteria

Unable to monitor BIS (eg cranial or intracranial surgery), not expected to survive one year, unable to consent, not expected to be contactable in one year, surgery with ‘wake-up’ test.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 9, 2026