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
All-cause mortality 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 all-cause mortality at 1 year (6.5% vs. 7.2%; HR 0.88, 95% CI 0.73 to 1.07).
Secondary outcomes
No significant difference in MI (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 all-cause mortality 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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