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Anesthesia depth may impact Long-Term survival in older surgery patients

NCT ID NCT04965324

Knowledge-focused Sponsor: Auckland City Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows over 6,600 elderly patients (aged 60+) who had major surgery to see if lighter anesthesia helps them live longer. The original trial found no difference in survival at one year, but this follow-up checks for effects beyond that, including on cancer recurrence and memory problems. Researchers aim to learn whether adjusting anesthesia depth can improve long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

6,644 people

The number who actually took part.

Started

Dec 2012

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All participants who were recruited to the BALANCED Trial and who met the inclusion and no exclusion criteria for analysis of the long term outcome.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion and exclusion criteria will be the same as the Balanced trial with participants limited to those sites described above. Survival data will be censored at date of accessing mortality database. Inclusion 1. Age over 60 years and over 2. ASA physical status 3 or 4 3. Surgery expected to last over 2 hours 4. Hospital length of stay expected to be 2 nights or more 5. General anaesthesia with or without major regional block 6. Able to monitor BIS throughout anaesthesia Exclusion 1. Unable to monitor BIS 2. Unable to consent 3. Surgery with 'wake up' test 4. Propofol infusion for part or all of maintenance of anaesthesia 5. Previous enrolment in Balanced study Exclusion The intention-to-treat (ITT) population is defined as all randomised participants who met the inclusion and exclusion criteria who had surgery. The per-protocol (PP) population is defined as all randomised participants in the study who meet all the inclusion/exclusion criteria for BALANCED with BIS group classified according to the actual median BIS value achieved irrespective of randomisation. Participants were allocated to the BIS=50 group if the achieved median BIS is between 45 and 55 inclusive, and to the BIS=35 group if the achieved median BIS is between 30 and 40 inclusive. Participants who are not within these ranges will be excluded from these analyses.

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Conditions

The condition(s) this trial relates to.

cognitive disorder delirium Long Term Adverse Effects Postoperative Cognitive Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive dysfunction, postoperative Long term adverse effects Post-operative confusion Surgery--complications

Contacts and locations

Locations

  • Auckland City Hopsital

    Auckland, Auckland, 1023, New Zealand

More trials for these conditions

Other studies related to the condition(s) this trial covers.