• Yongjun Liu, Zhiyong Peng, Songqiao Liu, Xiangyou Yu, Duming Zhu, Linlin Zhang, Jianli Wen, Youzhong An, Liying Zhan, Xiaochuang Wang, Yan Kang, Aijun Pan, Jing Yan, Lina Zhang, Fengming Liu, Jun Zeng, Qinhan Lin, Renhua Sun, Jiangquan Yu, Huaxue Wang, Li Yao, Chuanxi Chen, Ning Liu, Yao Nie, Jie Lyu, Kun Wu, Jianfeng Wu, Xiao Liu, and Xiangdong Guan.
• Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
• Crit. Care Med. 2023 Oct 1; 51 (10): 131813271318-1327.

ObjectivesTo determine the effectiveness and safety of ciprofol for sedating patients in ICUs who required mechanical ventilation (MV).DesignA multicenter, single-blind, randomized, noninferiority trial.SettingTwenty-one centers across China from December 2020 to June 2021.PatientsA total of 135 ICU patients 18 to 80 years old with endotracheal intubation and undergoing MV, who were expected to require sedation for 6-24 hours.InterventionsOne hundred thirty-five ICU patients were randomly allocated into ciprofol ( n = 90) and propofol ( n = 45) groups in a 2:1 ratio. Ciprofol or propofol were IV infused at loading doses of 0.1 mg/kg or 0.5 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Ciprofol or propofol were then immediately administered at an initial maintenance dose of 0.3 mg/kg/hr or 1.5 mg/kg/hr, to achieve the target sedation range of Richmond Agitation-Sedation Scale (+1 to -2). Besides, continuous IV remifentanil analgesia was administered (loading dose: 0.5-1 μg/kg, maintenance dose: 0.02-0.15 μg/kg/min).Measurements And Main ResultsOf the 135 patients enrolled, 129 completed the study. The primary endpoint-sedation success rates of ciprofol and propofol groups were 97.7% versus 97.8% in the full analysis set (FAS) and were both 100% in per-protocol set (PPS). The noninferiority margin was set as 8% and confirmed with a lower limit of two-sided 95% CI for the inter-group difference of -5.98% and -4.32% in the FAS and PPS groups. Patients who received ciprofol had a longer recovery time ( p = 0.003), but there were no differences in the remaining secondary endpoints (all p > 0.05). The occurrence rates of treatment-emergent adverse events (TEAEs) or drug-related TEAEs were not significantly different between the groups (all p > 0.05).ConclusionsCiprofol was well tolerated, with a noninferior sedation profile to propofol in Chinese ICU patients undergoing MV for a period of 6-24 hours.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.

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