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Introduction <p>This study evaluated the efficacy and safety of cipepofol vs. dexmedetomidine for long-term sedation of patients undergoing mechanical ventilation (MV) in an intensive care unit (ICU).</p> Methods <p>Adult patients who required invasive MV for ≥ 24&#xa0;h were given cipepofol or dexmedetomidine at a ratio of 1:1, with a target sedation goal of + 1 to −&#xa0;2 on the Richmond Agitation and Sedation Scale (RASS). The primary endpoint was the proportion of time patients spent within the target RASS range of − 2 to + 1.</p> Results <p>All 142 intention-to-treat (ITT) patients were randomized, with 74 receiving cipepofol and 68 dexmedetomidine. Patients receiving cipepofol exhibited a significantly higher median proportion of time spent within the target sedation range than those receiving dexmedetomidine (99.7% vs. 98.8%, <i>P</i> = 0.041). Following adjustment for imbalance in the baseline age, no significant difference of primary endpoint was noted between the groups. Patients given cipepofol exhibited potential advantages in greater successful sedation rates (85.1% vs. 50.0%, adjusted <i>P</i> &lt; 0.001) and early sedation success rates within 30-min administration (81.1% vs. 64.7%, adjusted <i>P</i> = 0.025), and a lower frequency of bradycardia (16.2% vs. 32.4%, adjusted <i>P</i> = 0.029) after adjusting for imbalance of baseline age. No differences were found between groups regarding ventilator-free days at day&#xa0;28, length of ICU stays, 28-day all-cause mortality or incidences of hypotension, tachycardia, hypertension or agitation. Post hoc analysis demonstrated that successful early sedation within 30-min administration was associated with less ventilator use, lower 28-day all-cause mortality, and lower incidences of hypotension, hypertension, tachycardia, and agitation, fewer dose adjustments of cipepofol/dexmedetomidine, but a slightly prolonged extubation time.</p> Conclusions <p>Cipepofol is a safe and effective alternative sedative for long-term sedation (≥ 24&#xa0;h) of Chinese ICU patients receiving MV, providing sedation performance comparable to dexmedetomidine, with some potential advantages in terms of stability and less need for rescue therapy.</p> Trial Registration <p>Chinese Clinical Trial Registry, identifier ChiCTR2300078671, retrospectively registered on December 14, 2023.</p> Plain Language Summary <p>Cipepofol is an analogue of propofol with approximately four- to five-fold greater potency that was initially approved for clinical use in China in 2019. Cipepofol was approved for use in critically ill patients requiring sedation during mechanical ventilation in July 2022, as both phase&#xa0;2 and phase&#xa0;3 clinical trials revealed that cipepofol had a favorable safety profile, with comparable sedation outcomes to that of propofol. However, studies of its use as compared to dexmedetomidine in the setting of mechanical ventilation for more than 24&#xa0;h are lacking. The present study is the first to demonstrate that cipepofol may serve as an effective and safe sedative agent compared to dexmedetomidine for long-term sedation. All 142 randomized patients receiving mechanical ventilation in the intensive care unit were enrolled from five centers in Changzhou (China), with 74 receiving cipepofol and 68 dexmedetomidine. The main findings demonstrated that cipepofol achieved slightly more consistent sedation than dexmedetomidine in critically ill patients undergoing mechanical ventilation, with less need for adjunctive therapy. Further post hoc analysis revealed that patients who achieved the sedation goal of + 1 to −&#xa0;2 on the Richmond Agitation and Sedation Scale without hypotension after 30-min administration had prolonged ventilator-free days, lower 28-day all-cause mortality, lower rates of hypotension, hypertension, tachycardia, and agitation, and fewer dose adjustments for cipepofol/dexmedetomidine. These results indicated that the early sedation achievement without hypotension after 30-min administration was associated with better long-term outcomes. However, all these results of post hoc analyses should be interpreted with caution owing to insufficient statistical power but warrant further investigation.</p>

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Long-Term Sedation Effect of Cipepofol Compared to Dexmedetomidine in Patients Receiving Invasive Mechanical Ventilation: A Multicenter, Randomized, Open-Label, Parallel-Controlled Study

  • 期刊论文

  • 发表日期：

    2026年5月30日

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  • Wanyi Li,
  • Minghui Zhu,
  • Wenbo Xu,
  • Weiyan Cui,
  • Hong Li,
  • Feng Xue,
  • Zhaoquan Jin,
  • Chuan Chen,
  • Bo Yang,
  • Mingfen Sun,
  • Fan Huang,
  • Dan Zhou,
  • Dong Yuan,
  • Daming Wang,
  • Chang Chu

摘要

Introduction

This study evaluated the efficacy and safety of cipepofol vs. dexmedetomidine for long-term sedation of patients undergoing mechanical ventilation (MV) in an intensive care unit (ICU).

Methods

Adult patients who required invasive MV for ≥ 24 h were given cipepofol or dexmedetomidine at a ratio of 1:1, with a target sedation goal of + 1 to − 2 on the Richmond Agitation and Sedation Scale (RASS). The primary endpoint was the proportion of time patients spent within the target RASS range of − 2 to + 1.

Results

All 142 intention-to-treat (ITT) patients were randomized, with 74 receiving cipepofol and 68 dexmedetomidine. Patients receiving cipepofol exhibited a significantly higher median proportion of time spent within the target sedation range than those receiving dexmedetomidine (99.7% vs. 98.8%, P = 0.041). Following adjustment for imbalance in the baseline age, no significant difference of primary endpoint was noted between the groups. Patients given cipepofol exhibited potential advantages in greater successful sedation rates (85.1% vs. 50.0%, adjusted P < 0.001) and early sedation success rates within 30-min administration (81.1% vs. 64.7%, adjusted P = 0.025), and a lower frequency of bradycardia (16.2% vs. 32.4%, adjusted P = 0.029) after adjusting for imbalance of baseline age. No differences were found between groups regarding ventilator-free days at day 28, length of ICU stays, 28-day all-cause mortality or incidences of hypotension, tachycardia, hypertension or agitation. Post hoc analysis demonstrated that successful early sedation within 30-min administration was associated with less ventilator use, lower 28-day all-cause mortality, and lower incidences of hypotension, hypertension, tachycardia, and agitation, fewer dose adjustments of cipepofol/dexmedetomidine, but a slightly prolonged extubation time.

Conclusions

Cipepofol is a safe and effective alternative sedative for long-term sedation (≥ 24 h) of Chinese ICU patients receiving MV, providing sedation performance comparable to dexmedetomidine, with some potential advantages in terms of stability and less need for rescue therapy.

Trial Registration

Chinese Clinical Trial Registry, identifier ChiCTR2300078671, retrospectively registered on December 14, 2023.

Plain Language Summary

Cipepofol is an analogue of propofol with approximately four- to five-fold greater potency that was initially approved for clinical use in China in 2019. Cipepofol was approved for use in critically ill patients requiring sedation during mechanical ventilation in July 2022, as both phase 2 and phase 3 clinical trials revealed that cipepofol had a favorable safety profile, with comparable sedation outcomes to that of propofol. However, studies of its use as compared to dexmedetomidine in the setting of mechanical ventilation for more than 24 h are lacking. The present study is the first to demonstrate that cipepofol may serve as an effective and safe sedative agent compared to dexmedetomidine for long-term sedation. All 142 randomized patients receiving mechanical ventilation in the intensive care unit were enrolled from five centers in Changzhou (China), with 74 receiving cipepofol and 68 dexmedetomidine. The main findings demonstrated that cipepofol achieved slightly more consistent sedation than dexmedetomidine in critically ill patients undergoing mechanical ventilation, with less need for adjunctive therapy. Further post hoc analysis revealed that patients who achieved the sedation goal of + 1 to − 2 on the Richmond Agitation and Sedation Scale without hypotension after 30-min administration had prolonged ventilator-free days, lower 28-day all-cause mortality, lower rates of hypotension, hypertension, tachycardia, and agitation, and fewer dose adjustments for cipepofol/dexmedetomidine. These results indicated that the early sedation achievement without hypotension after 30-min administration was associated with better long-term outcomes. However, all these results of post hoc analyses should be interpreted with caution owing to insufficient statistical power but warrant further investigation.