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Category: Research

Star Research Presentation: Pharmacology and Nutrition

(370007-19) Reduction of Delirium and Sedative Drug Doses by BIS-Guided Deep Sedation in the ICU: Clinical Trial

Sunday, January 21, 2024
3:00 PM – 3:10 PM MT
Location: Connections Central - Star Research Theater
Disclosure(s):
Ivan A. Huespe, MD: No relevant financial relationship(s) to disclose.


Introduction: Delirium is common in critical patients undergoing deep sedation, often due to excessive sedative drug use. The Bispectral Index (BIS) is a potential tool to mitigate this risk. This trial compares delirium and sedative drug doses in ICU patients under BIS-guided vs. Clinical Scales (CS) sedation.

Methods: Randomized, controlled, double-blinded trial in an Argentinean hospital (April 2019 to December 2021, NCT03840577). Inclusion criteria: deep sedation >8 hours (excl. neurocritical patients). Randomization into control (Richmond Agitation-Sedation Scale) or BIS group (BIS target 40-60). Both groups used a BIS sensor (controls with the screen covered). After the end of deep sedation BIS sensors were removed and delirium was assessed twice daily for 14 days using the Confusion Assessment Method for the ICU by researchers blinded to the randomization. Outcomes: coma- and delirium-free days (T-test), subgroup analysis of patients with >24 hours sedation, and sedative drug doses (Mixed effect model).

Results: 99 patients were included (BIS=50, SC=49). Deep sedation duration was similar in both groups (BIS median 2.21[IQR 1.3-3.4]; CS 2.7[IQR 1-4] days). The BIS group had a mean of 7.58 (SD 5.8) delirium-free days vs. 5.6 (SD 6.1) (p=0.1). Subgroup analysis in patients with >24 hours of sedation showed more delirium-free days in the BIS group (BIS 6.9 [SD 5.8]; SC 3.5 [SD 5.3]; p< 0.01).
Propofol dose was 10% lower in the BIS group (mean 1.29 vs. 1.44 mg/kg/h; p< 0.01), with lower doses since deep sedation started (coef. BIS -0.23 [95%CI -0.46/-0.001]; p< 0.01). Both groups had the same dose reduction over time (coef. of hours -.018 [95%CI 0.02/0.01]; p< 0.01), without intergroup differences (coef. interaction term BIS*hours -0.004 [95%CI -0.01 / 0.1];p=0.1).
Midazolam dose was 19% lower in the BIS group (0.16 vs. 0.21 mg/kg/h; p< 0.01), without differences when deep sedation started (0.01 [95%CI -0.04/0.06]; p=0.7), but with an increase over time in the SC group (coef. of hours 0.003 [95%CI 0.006/0.004]) and stable in the BIS group (coef. interaction term BIS*hours -0.004 [95%CI -0.005 /-0.004]).

Conclusions: BIS-guided deep sedation reduced sedative drugs but only improved delirium and coma-free days in patients that required >24 hours of sedation.