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Purpose <p>To explore the efficacy and safety of remimazolam besylate in short-term sedation in the ICU in comparison with propofol.</p> Method <p>A multicenter, randomized, single-blind, non-inferiority trial was conducted in mechanically ventilated patients, who needed light sedation, defined as Richmond Agitation–Sedation Scale (RASS) scores between −2 and + 1. The primary outcome was successful sedation, which was defined as no rescue sedative administered during the study drug infusion period while maintaining RASS scores between –2 and + 1 for at least 70% of the total infusion time.</p> Results <p>A total of 164 participants were included and randomized equally into the remimazolam group and the propofol group. Remimazolam was continuously infused for 10.5 [8.1–14.7] h and propofol for 11.0 [7.0–14.3] h (<i>p</i> = 0.534). The median average maintaining dose of remimazolam and propofol was 0.20 [0.19–0.30] mg·kg⁻<sup>1</sup>·h⁻<sup>1</sup> and 0.61 [0.30–1.17] mg·kg⁻<sup>1</sup>·h⁻<sup>1</sup>, respectively. The percentage of participants successfully sedated in both groups was 97.5% (<i>p</i> = 0.497) with a difference of 0 (95% confidence interval (CI) −6.5% to 6.4%), above the predefined non-inferiority margin of −8%. There was no significant difference in the mean percentage of time with target RASS scores between the remimazolam group (88.6%; 95% CI: 84.2%–92.9%) and the propofol group (89.4%; 95% CI: 85.0%–93.8%) (<i>p</i> = 0.543).</p> Conclusion <p>Remimazolam besylate could be non-inferior to propofol for achieving successful short-term light sedation in the ICU.</p> Trial registration <p>ClinicalTrials.gov identifier: NCT05782894 on Feb 18th, 2023.</p> Graphical Abstract <p></p>

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Short-term light sedation with remimazolam besylate versus propofol in the ICU (SHOSREB): a multicentre, randomized, single-blind, controlled trial

  • 期刊论文

  • 发表日期：

    2026年3月31日

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  • Xiaobo Yang,
  • Jingye Pan,
  • Xun Gong,
  • Ailian Lv,
  • Fengming Liang,
  • Jing Liu,
  • Dezhong Li,
  • Shouzhi Fu,
  • Aijun Pan,
  • Li Yu,
  • Lina Zhang,
  • Tao Chen,
  • Liying Zhan,
  • Bingyu Qin,
  • Fenghui Lin,
  • Xuming Xiong,
  • Ying Zhu,
  • Zhihui He,
  • Renhua Sun,
  • Tongwen Sun,
  • Songzan Qian,
  • Deliang Wen,
  • Xiaojing Zou,
  • Hong Qi,
  • Huaqing Shu,
  • Liping Song,
  • Chunhua Wang,
  • You Shang

摘要

Purpose

To explore the efficacy and safety of remimazolam besylate in short-term sedation in the ICU in comparison with propofol.

Method

A multicenter, randomized, single-blind, non-inferiority trial was conducted in mechanically ventilated patients, who needed light sedation, defined as Richmond Agitation–Sedation Scale (RASS) scores between −2 and + 1. The primary outcome was successful sedation, which was defined as no rescue sedative administered during the study drug infusion period while maintaining RASS scores between –2 and + 1 for at least 70% of the total infusion time.

Results

A total of 164 participants were included and randomized equally into the remimazolam group and the propofol group. Remimazolam was continuously infused for 10.5 [8.1–14.7] h and propofol for 11.0 [7.0–14.3] h (p = 0.534). The median average maintaining dose of remimazolam and propofol was 0.20 [0.19–0.30] mg·kg⁻1·h⁻1 and 0.61 [0.30–1.17] mg·kg⁻1·h⁻1, respectively. The percentage of participants successfully sedated in both groups was 97.5% (p = 0.497) with a difference of 0 (95% confidence interval (CI) −6.5% to 6.4%), above the predefined non-inferiority margin of −8%. There was no significant difference in the mean percentage of time with target RASS scores between the remimazolam group (88.6%; 95% CI: 84.2%–92.9%) and the propofol group (89.4%; 95% CI: 85.0%–93.8%) (p = 0.543).

Conclusion

Remimazolam besylate could be non-inferior to propofol for achieving successful short-term light sedation in the ICU.

Trial registration

ClinicalTrials.gov identifier: NCT05782894 on Feb 18th, 2023.

Graphical Abstract