Dose-Response Relationship of Single Intravenous Remimazolam on Bispectral Index and Cardiorespiratory Effects.
Jianxiao Chen, Jianqiao Luo, Honglan Ye et al.
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From the abstract
The Bispectral Index (BIS) is a standardized, continuous measure of sedation depth. Studies have shown that remimazolam can induce a decrease in BIS, but the dose-response relationship between single-dose remimazolam and BIS remains unclear.
Reported results
BIS values decreased more significantly with increasing remimazolam doses, with a plateau effect observed above 0.4 mg/kg. The BISmin values for each group were 60.6 ± 10.4, 58.4 ± 9.2, 58.1 ± 6.2, 55.6 ± 7.9, and 55.0 ± 6.4, respectively. Using the BIS ≤ 60 threshold, the ED 50 and ED 90 were 0.317 mg/kg (95% CI: 0.187-0.415 mg/kg) and 1.172 mg/kg (95% CI: 0.704-13.959 mg/kg), respectively.
Authors' conclusions
A dose-dependent relationship exists between single-dose remimazolam and BIS, with good respiratory and circulatory safety in the 0.2-0.6 mg/kg range and a plateau effect above 0.4 mg/kg. The extremely wide confidence interval for the ED 90 estimated using the BIS ≤ 60 threshold suggests that this endpoint may not be suitable for pharmacodynamic evaluation of single-dose remimazolam.