The BALANCED Anaesthesia Study: A prospective, randomised clinical trial of two levels of anaesthetic depth on patient outcome after major surgery

The BALANCED Anaesthesia Study: A prospective, randomised clinical trial of two levels of anaesthetic depth on patient outcome after major surgery - The BALANCED study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43559

Enrollment

200

Registered

2017-02-15

Start date

2016-08-04

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Complications of anaesthesia

Interventions

Anaesthesia

Anaesthetic depth

Mortality

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: *60 years ASA physical status 3 or 4 Surgery lasting *2 hours Post-op hospital stay *2 nights General anaesthesia with or without major regional block Able to monitor BIS

Exclusion criteria

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
Primary hypothesis Light general anaesthesia (BIS = 50) is associated with decreased all cause mortality compared with deep general anaesthesia (BIS = 35) one year after major surgery in elderly patients.	—

Secondary

Measure	Time frame
Secondary hypotheses Light general anaesthesia (BIS = 50) is associated with decreased incidences of MI, cardiac arrest, PE, stroke, sepsis and surgical site infection compared with deep general anaesthesia (BIS = 35) at 30 days and one year after major surgery in elderly patients. Light general anaesthesia (BIS = 50) is associated with decreased incidences of a composite endpoint of MI, cardiac arrest, PE and stroke compared with deep general anaesthesia (BIS = 35) at 30 days and one year after major surgery in elderly patients. Light general anaesthesia (BIS = 50) is associated with decreased cancer recurrence compared with deep general anaesthesia (BIS = 35) one year after major surgery in elderly patients. Light general anaesthesia (BIS=50) is associated with an increased incidence of persistent postoperative pain compared with deep anaesthesia (BIS=35) at 30 days and one year after surgery in elderly patients. Light anaesthesia (BIS = 50) is associated with increased disability-free survival compared with deep general anaesthesia (BIS = 35) one year after major surgery in elderly patients. Safety and quality hypotheses Light general anaesthesia (BIS = 50) is associated with improved early quality of recovery compared with deep general anaesthesia (BIS = 35) after major surgery in elderly patients. Light general anaesthesia (BIS = 50) does not increase the incidence of awareness compared with deep general anaesthesia (BIS = 35) after major surgery in elderly patients.	—

Measure

Time frame

Secondary hypotheses Light general anaesthesia (BIS = 50) is associated with decreased incidences of MI, cardiac arrest, PE, stroke, sepsis and surgical site infection compared with deep general anaesthesia (BIS = 35) at 30 days and one year after major surgery in elderly patients. Light general anaesthesia (BIS = 50) is associated with decreased incidences of a composite endpoint of MI, cardiac arrest, PE and stroke compared with deep general anaesthesia (BIS = 35) at 30 days and one year after major surgery in elderly patients. Light general anaesthesia (BIS = 50) is associated with decreased cancer recurrence compared with deep general anaesthesia (BIS = 35) one year after major surgery in elderly patients. Light general anaesthesia (BIS=50) is associated with an increased incidence of persistent postoperative pain compared with deep anaesthesia (BIS=35) at 30 days and one year after surgery in elderly patients. Light anaesthesia (BIS = 50) is associated with increased disability-free survival compared with deep general anaesthesia (BIS = 35) one year after major surgery in elderly patients. Safety and quality hypotheses Light general anaesthesia (BIS = 50) is associated with improved early quality of recovery compared with deep general anaesthesia (BIS = 35) after major surgery in elderly patients. Light general anaesthesia (BIS = 50) does not increase the incidence of awareness compared with deep general anaesthesia (BIS = 35) after major surgery in elderly patients.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)