BALANCED
Trial question
What is the role of light general anesthesia among patients at increased risk of complications after major surgery?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 6644
6644 patients (2423 female, 4221 male)
Inclusion criteria: patients with increased risk of complications after major surgery
Key exclusion criteria: inability to place electrodes and monitor the bispectral index because of the site of surgery; planned wake-up test; use of nitrous oxide, propofol infusion for maintenance of anesthesia, or ketamine at an infusion rate > 25 mg/hr
Interventions
N=3316 light general anesthesia (bispectral index target 50)
N=3328 deep general anesthesia (bispectral index target 35)
Primary outcome
Death from all causes at 1 year
6.5
7.2
7.2 %
5.4 %
3.6 %
1.8 %
0.0 %
Light general
anesthesia
Deep general
anesthesia
No significant
difference ↔
No significant difference in death from all causes at 1 year (6.5% vs. 7.2%; HR 0.88, 95% CI 0.73 to 1.07)
Secondary outcomes
No significant difference in myocardial infarction (2% vs. 2%; HR 1, 95% CI 0.73 to 1.38)
No significant difference in PE (1% vs. 1%; HR 0.77, 95% CI 0.49 to 1.22)
Safety outcomes
No significant difference in grade 3 and grade 4 adverse events.
Conclusion
In patients with increased risk of complications after major surgery, light general anesthesia was not superior to deep general anesthesia with respect to death from all causes at 1 year.
Reference
Timothy G Short, Douglas Campbell, Christopher Frampton et al. Anaesthetic depth and complications after major surgery: an international, randomised controlled trial. Lancet. 2019 Nov 23;394(10212):1907-1914.
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