The BALANCED Anaesthesia Study

The BALANCED Anaesthesia Study A Prospective, Randomised Clinical Trial of Two Levels of Anaesthetic Depth on Patient Outcome After Major Surgery

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02073357

Enrollment

Registered

2014-02-27

Start date

2014-07-31

Completion date

Unknown

Last updated

2014-07-31

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

Conditions

Effect of General Anesthetic Dose on Recovery From Surgery

Brief summary

General anaesthesia is a reversible drug-induced coma. Too little can result in patients being partially conscious during surgery; too much can slow recovery after surgery. There is a range of drug doses that can be used and some anesthesiologists use more than others. There is no convincing evidence that any particular dose within the usual range is better. Consequently, there are no guidelines on the best depth of anaesthesia. This study will determine whether general anesthetic concentrations at the low end of the usual range are better than those at the high end. Participants will randomly be assigned to lighter or deeper general anesthesia. The first day after surgery, two short questionnaires about recovery and memories of the surgery will be completed. During the rest of the participant's hospital stay, a survey about how one feels will be completed. There will be two telephone contacts after discharge from the hospital. One month after surgery three questionnaires will be completed about performing daily tasks, how you feel and memories of the surgery. Then one year after surgery pain will be assessed.

Interventions

PROCEDURELight general anaesthesia (BIS = 50)

PROCEDUREdeep general anaesthesia (BIS = 35)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥60 years * ASA physical status 3 or 4 * surgery expected to last ≥2 hours * post-operative hospital stay expected to be ≥2 nights * general anaesthesia with or without major regional block * able to monitor BIS throughout anaesthesia

Exclusion criteria

* Unable to monitor BIS (e.g. cranial or intracranial surgery) * unable to consent * surgery with 'wake-up' test * propofol infusion for part or all of maintenance of anaesthesia ('total intravenous anaesthesia') * previous enrolment in Balanced study

Design outcomes

Primary

Measure	Time frame
One-year all-cause mortality	One year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026