Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials.

IF 5.7 1区 医学 Q1 CRITICAL CARE MEDICINE Annals of Intensive Care Pub Date : 2024-10-26 DOI:10.1186/s13613-024-01390-3
Yongjun Liu, Lingyun Zuo, Xiaoyun Li, Yao Nie, Chuanxi Chen, Ning Liu, Minying Chen, Jianfeng Wu, Xiangdong Guan
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Abstract

Background: Ciprofol was approved for use in intensive care unit (ICU) patients requiring sedation during mechanical ventilation in July 2022. A pooled post-hoc analysis of phase 2 and phase 3 trials was conducted primarily to explore hypotension-free outcome in ICU patients who required mechanical ventilation and achieved the target light sedation goal at an early stage after being sedated with ciprofol or propofol.

Methods: All eligible ICU patients who were expected to require sedation for 6-24 h were randomly assigned in a 2:1 ratio to either a ciprofol or propofol group. Ciprofol or propofol was initially infused at loading doses of 0.5 or 1.0 mg/kg followed by maintenance doses of 0.3 or 1.5 mg/kg/h. Ciprofol or propofol dosages were adjusted up or down at rates of 0.05-0.10 mg/kg/h or 0.25-0.50 mg/kg/h, respectively, to achieve the target light sedation (a Richmond Agitation-Sedation Scale of -2 to + 1). The primary post-hoc outcome was the hypotension-free rate in patients who had achieved the target sedation goal after 30-min administration of ciprofol or propofol.

Results: In total, 174 patients were enrolled for pooled post-hoc analysis, of whom 116 and 58 were assigned to the ciprofol and propofol groups, respectively. The hypotension-free rate was significantly higher in patients who achieved the target sedation goal after 30-min administration of ciprofol (93.0% vs. 81.0%, P = 0.018), and especially in the subgroups of males and patients aged < 65 years. Multivariable analysis revealed that ciprofol treatment, a younger age and lower baseline body mass index were independent favorable predictors for a higher hypotension-free rate in patients who achieved the target sedation goal after 30-min of drug administration. Moreover, hypotension-free patients who reached the target sedation level after 30 min had a more favorable short-term prognosis including a lower incidence of drug-related treatment-emergent adverse events, shorter time to extubation and fewer dose adjustments of ciprofol or propofol (all P < 0.05).

Conclusion: ICU patients undergoing mechanical ventilation and sedated with ciprofol had significantly lower rate of hypotension during the early phase of achieving light sedation during a 6-24 h period, leading to a more favorable short-term prognosis (within 24 h).

Trial registration: Phase 2 trial (clinicaltrials.gov, NCT04147416. Registered November 1, 2019, https://classic.

Clinicaltrials: gov/ct2/show/NCT04147416 ) and phase 3 trial (clinicaltrials.gov, NCT04620031. Registered November 6, 2020, https://classic.

Clinicaltrials: gov/ct2/show/NCT04620031 ).

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对需要机械通气的重症监护室患者使用环丙酚进行早期镇静:对第 2 期和第 3 期试验数据的汇总后分析。
背景:2022 年 7 月,Ciprofol 被批准用于需要在机械通气期间使用镇静剂的重症监护病房(ICU)患者。我们对2期和3期试验进行了汇总后分析,主要是为了探讨需要机械通气的ICU患者在使用异丙酚或丙泊酚镇静后,早期达到目标轻度镇静目标的无低血压结局:所有符合条件、预计需要镇静 6-24 小时的 ICU 患者均按 2:1 的比例随机分配到异丙酚组或丙泊酚组。首先以 0.5 或 1.0 毫克/千克的负荷剂量输注环丙酚或异丙酚,然后以 0.3 或 1.5 毫克/千克/小时的维持剂量输注。环丙酚或丙泊酚的剂量分别以 0.05-0.10 mg/kg/h 或 0.25-0.50 mg/kg/h 的速度上下调整,以达到目标的轻度镇静(里士满躁动-镇静量表为 -2 至 +1)。事后研究的主要结果是,在使用异丙酚或丙泊酚 30 分钟后达到目标镇静目标的患者中,无低血压率:共有 174 名患者参与了汇总的事后分析,其中 116 人和 58 人分别被分配到环丙酚组和丙泊酚组。给药 30 分钟后达到目标镇静目标的患者无低血压率明显更高(93.0% vs. 81.0%,P = 0.018),尤其是在男性和老年患者亚组中:接受机械通气并使用环丙酚镇静的重症监护病房患者在实现轻度镇静的早期阶段(6-24 小时内)发生低血压的比例明显较低,从而导致更有利的短期预后(24 小时内):2期试验(clinicaltrials.gov,NCT04147416.注册时间为 2019 年 11 月 1 日,https://classic.Clinicaltrials: gov/ct2/show/NCT04147416 )和 3 期试验(clinicaltrials.gov, NCT04620031.注册时间为 2020 年 11 月 6 日,https://classic.Clinicaltrials: gov/ct2/show/NCT04620031 )。
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来源期刊
Annals of Intensive Care
Annals of Intensive Care CRITICAL CARE MEDICINE-
CiteScore
14.20
自引率
3.70%
发文量
107
审稿时长
13 weeks
期刊介绍: Annals of Intensive Care is an online peer-reviewed journal that publishes high-quality review articles and original research papers in the field of intensive care medicine. It targets critical care providers including attending physicians, fellows, residents, nurses, and physiotherapists, who aim to enhance their knowledge and provide optimal care for their patients. The journal's articles are included in various prestigious databases such as CAS, Current contents, DOAJ, Embase, Journal Citation Reports/Science Edition, OCLC, PubMed, PubMed Central, Science Citation Index Expanded, SCOPUS, and Summon by Serial Solutions.
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