Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol

被引:36
作者
Liu, Yongjun [1 ]
Chen, Chuanxi [1 ]
Liu, Ning [1 ]
Tong, Li [1 ]
Nie, Yao [1 ]
Wu, Jianfeng [1 ]
Liu, Xiao [2 ]
Gao, Wei [2 ]
Tang, Lei [3 ]
Guan, Xiangdong [1 ]
机构
[1] Sun Yat Sen Univ, Affiliated Hosp 1, Dept Crit Care Med, 58 Zhongshan 2nd Rd, Guangzhou 510080, Guangdong, Peoples R China
[2] Haisco Pharmaceut Grp Co Ltd, Dept Med, Shanghai, Peoples R China
[3] Sun Yat Sen Univ, Affiliated Hosp 1, Dept Good Clin Practice, Guangzhou, Peoples R China
关键词
Propofol; Sedation; Anesthesia; Mechanical ventilation; Ciprofol; CRITICALLY-ILL PATIENTS; PROPOFOL; DEXMEDETOMIDINE; DELIRIUM; ADULTS; IMPACT; SLEEP; PAIN;
D O I
10.1007/s12325-021-01877-6
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Introduction: From previous studies of pharmacodynamic data in mice, rats, beagle dogs and mini pigs, frequently in direct comparison to induction doses of propofol, ciprofol produced a rapid onset of anesthesia/sedation. Methods: A phase 1 study suggested potential clinical advantages of ciprofol as a sedation/anesthetic agent, with no evidence of drug-related toxicity. However, the sedation effects and safety of ciprofol in intensive care unit (ICU) patients with mechanical ventilation should be further confirmed in a phase 3 study with a larger cohort of patients. During a phase 3, non- inferiority, multicenter, single-blind, randomized, propofol controlled trial, Chinese ICU patients undergoing mechanical ventilation and requiring endotracheal intubation will be sedated for 6-24 h after randomization. Considering a success rate for ICU sedation of 99% for ciprofol and the positive control drug propofol, a total sample size of 120 subjects with mechanical ventilation will be required to achieve 80% power to determine non-inferiority with a margin of 8%. Finally, taking into account 10% losses, 135 patients will be enrolled and randomly assigned to ciprofol (90 cases) and propofol (45 cases) groups in a 2:1 ratio. The primary outcome will be the success rate of sedation satisfied by the following conditions: the time within the range of Richmond Agitation and Sedation Score (+ 1 similar to -2) must account for >= 70% of the study drug administration time and without other rescue treatments. Secondary outcomes will include the average time to reach the sedation goal, study drug usage, rescue medication given per unit weight, extubation time, recovery time to full consciousness and nursing scores. Safety endpoints will include adverse events (AEs), drug related AEs and serious AEs. Planned Outcomes: The results of this study will provide crucial information on the use of ciprofol for sedation of patients in ICUs.
引用
收藏
页码:5412 / 5423
页数:12
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