环丙泊酚用于重症监护病房躁动和谵妄的疗效与安全性：一项多中心、单盲、三臂平行随机对照试验研究方案
Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol.
作者信息
Liu Guo Liang, Wu Guo Zhi, Ge Dong, Zhou Heng Jie, Cui Song, Gao Kai, Sun Wei Jia, Yu Dong Hai, Liu Si Bo, Liu Jin Jie
机构信息
Intensive Care Unit, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China.
Department of Pharmacy, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China.
出版信息
Front Med (Lausanne). 2023 Jan 9;9:1024762. doi: 10.3389/fmed.2022.1024762. eCollection 2022.
BACKGROUND
Agitation is very common in the intensive care unit (ICU). The causes include pain, delirium, underlying disease, withdrawal syndrome, and some drug treatments. The practical goal of ICU treatment is to find an appropriate sedation regimen to reduce pain, restlessness, and delirium. Previous trials have examined the use of dexmedetomidine, but no trials have evaluated the efficacy and safety of ciprofol, a new sedative drug.
METHODS
This study was a multicenter, single-blind, 3-arm parallel randomized controlled trial. ICU patients aged ≥ 18 years with agitation and delirium who met the eligibility criteria were included. The main outcome was the proportion of patients who needed additional study medication or midazolam due to agitation within 4 h after the first intravenous injection of the study medication. The secondary outcomes included the pass rate as indicated by a Richmond Agitation-Sedation Scale (RASS) score < +1, the effectiveness rate of improving delirium symptoms, the number of recurrences of agitation within 24 h, the incidence of rescue treatment, the dose and cost of analgesic and sedative drugs, the length and cost of ICU stay, and the 30-day survival period. The safety evaluation included the incidence of adverse events (hypotension, bradycardia, hypoxia, etc.) and the rate of endotracheal intubation. The subjects were randomly assigned to receive ciprofol, dexmedetomidine, or normal saline at a ratio of 1:1:1. The rates of additional drug administration within 4 h after the first injection of the study drug in the three groups were 40, 50, and 90%, respectively. A total sample size of 81 subjects was required to reach 90% power and an α of 0.05. Considering a 20% loss rate, 102 patients were enrolled and randomly assigned to the three groups in equal proportions.
ETHICS AND COMMUNICATION
This trial was approved by the Ethics Committee of Dalian Municipal Central Hospital. The communication plan includes presentations at scientific conferences, scientific publications, and presentations to the public through non-professional media.
CLINICAL TRIAL REGISTRATION
www.ClinicalTrials.gov, identifier ChiCTR220006 2799.
背景
躁动在重症监护病房（ICU）非常常见。其原因包括疼痛、谵妄、基础疾病、戒断综合征以及一些药物治疗。ICU治疗的实际目标是找到一种合适的镇静方案，以减轻疼痛、躁动和谵妄。以往的试验研究了右美托咪定的使用，但尚无试验评估新型镇静药物环丙泊酚的疗效和安全性。
方法
本研究为一项多中心、单盲、三臂平行随机对照试验。纳入年龄≥18岁、符合入选标准的伴有躁动和谵妄的ICU患者。主要结局是首次静脉注射研究药物后4小时内因躁动需要额外使用研究药物或咪达唑仑的患者比例。次要结局包括Richmond躁动镇静量表（RASS）评分<+1所显示的通过率、谵妄症状改善有效率、24小时内躁动复发次数、抢救治疗发生率、镇痛和镇静药物的剂量及费用、ICU住院时间及费用以及30天生存期。安全性评估包括不良事件（低血压、心动过缓、缺氧等）发生率和气管插管率。受试者按1:1:1的比例随机分配接受环丙泊酚、右美托咪定或生理盐水。三组在首次注射研究药物后4小时内额外用药率分别为40%、50%和90%。需要81例受试者的总样本量才能达到90%的检验效能和0.05的α水平。考虑到20%的失访率，共纳入102例患者并等比例随机分配至三组。
伦理与交流
本试验经大连市中心医院伦理委员会批准。交流计划包括在科学会议上发表演讲、发表科学论文以及通过非专业媒体向公众进行演讲。
临床试验注册
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