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Background <p>Short-term sedation is frequently required in postoperative intensive care unit (ICU) patients undergoing mechanical ventilation to ensure comfort and ventilator synchrony. Propofol is commonly used for this purpose but is often associated with hemodynamic instability. Remimazolam, an ultra-short-acting benzodiazepine, may provide effective sedation with improved hemodynamic safety; however, evidence for its use in the ICU setting remains limited.</p> Methods <p>In this single-center, prospective, randomized controlled study, postoperative ICU patients requiring mechanical ventilation were randomly assigned to receive remimazolam or propofol for short-term sedation. Sedation depth was continuously monitored using the bispectral index (BIS) and adjusted to maintain target sedation levels. Sedation duration, proportion of time within the target BIS range, sedative adjustment frequency, and adverse events were recorded and compared between groups.</p> Results <p>A total of 110 patients were enrolled and randomized (55 per group). Sedation duration and the proportion of time within the target BIS range were comparable between the remimazolam and propofol groups (0.976 vs. 0.974, P = 0.475), indicating similar sedative efficacy. Sedation stability assessed by dynamic BIS and hemodynamic monitoring was also comparable between groups. The incidence of hypotension was significantly lower in the remimazolam group than in the propofol group (2 vs. 9 patients, P = 0.026). No significant differences were observed in the incidence of bradycardia or delirium.</p> Conclusions <p>Remimazolam achieved sedation efficacy comparable to propofol and was associated with a lower incidence of hypotension in this single-center study. Larger multicenter studies are required to confirm these findings and to evaluate whether reduced hypotension translates into improvements in patient-centered outcomes.</p> <p><i>Trial registration</i>: This study was retrospectively registered at the Chinese Clinical Trial Registry (<a href="http://www.chictr.org.cn">www.chictr.org.cn</a>, ChiCTR2400083937). Trial registration was completed on May 8, 2024.</p>

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Bispectral index-guided comparison of remimazolam versus propofol for short-term sedation in mechanically ventilated postoperative ICU patients: a prospective randomized controlled trial

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  • 发表日期：

    2026年3月19日

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  • Zhenping Wu,
  • Hu Zhao,
  • Yun Zhang,
  • Yiqi Zhang,
  • Xia Zheng

摘要

Background

Short-term sedation is frequently required in postoperative intensive care unit (ICU) patients undergoing mechanical ventilation to ensure comfort and ventilator synchrony. Propofol is commonly used for this purpose but is often associated with hemodynamic instability. Remimazolam, an ultra-short-acting benzodiazepine, may provide effective sedation with improved hemodynamic safety; however, evidence for its use in the ICU setting remains limited.

Methods

In this single-center, prospective, randomized controlled study, postoperative ICU patients requiring mechanical ventilation were randomly assigned to receive remimazolam or propofol for short-term sedation. Sedation depth was continuously monitored using the bispectral index (BIS) and adjusted to maintain target sedation levels. Sedation duration, proportion of time within the target BIS range, sedative adjustment frequency, and adverse events were recorded and compared between groups.

Results

A total of 110 patients were enrolled and randomized (55 per group). Sedation duration and the proportion of time within the target BIS range were comparable between the remimazolam and propofol groups (0.976 vs. 0.974, P = 0.475), indicating similar sedative efficacy. Sedation stability assessed by dynamic BIS and hemodynamic monitoring was also comparable between groups. The incidence of hypotension was significantly lower in the remimazolam group than in the propofol group (2 vs. 9 patients, P = 0.026). No significant differences were observed in the incidence of bradycardia or delirium.

Conclusions

Remimazolam achieved sedation efficacy comparable to propofol and was associated with a lower incidence of hypotension in this single-center study. Larger multicenter studies are required to confirm these findings and to evaluate whether reduced hypotension translates into improvements in patient-centered outcomes.

Trial registration: This study was retrospectively registered at the Chinese Clinical Trial Registry (www.chictr.org.cn, ChiCTR2400083937). Trial registration was completed on May 8, 2024.