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Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial
OBJECTIVES: To determine the effectiveness and safety of ciprofol for sedating patients in ICUs who required mechanical ventilation (MV). DESIGN: A multicenter, single-blind, randomized, noninferiority trial. SETTING: Twenty-one centers across China from December 2020 to June 2021. PATIENTS: A total...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10497206/ https://www.ncbi.nlm.nih.gov/pubmed/37272947 http://dx.doi.org/10.1097/CCM.0000000000005920 |
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author | Liu, Yongjun Peng, Zhiyong Liu, Songqiao Yu, Xiangyou Zhu, Duming Zhang, Linlin Wen, Jianli An, Youzhong Zhan, Liying Wang, Xiaochuang Kang, Yan Pan, Aijun Yan, Jing Zhang, Lina Liu, Fengming Zeng, Jun Lin, Qinhan Sun, Renhua Yu, Jiangquan Wang, Huaxue Yao, Li Chen, Chuanxi Liu, Ning Nie, Yao Lyu, Jie Wu, Kun Wu, Jianfeng Liu, Xiao Guan, Xiangdong |
author_facet | Liu, Yongjun Peng, Zhiyong Liu, Songqiao Yu, Xiangyou Zhu, Duming Zhang, Linlin Wen, Jianli An, Youzhong Zhan, Liying Wang, Xiaochuang Kang, Yan Pan, Aijun Yan, Jing Zhang, Lina Liu, Fengming Zeng, Jun Lin, Qinhan Sun, Renhua Yu, Jiangquan Wang, Huaxue Yao, Li Chen, Chuanxi Liu, Ning Nie, Yao Lyu, Jie Wu, Kun Wu, Jianfeng Liu, Xiao Guan, Xiangdong |
author_sort | Liu, Yongjun |
collection | PubMed |
description | OBJECTIVES: To determine the effectiveness and safety of ciprofol for sedating patients in ICUs who required mechanical ventilation (MV). DESIGN: A multicenter, single-blind, randomized, noninferiority trial. SETTING: Twenty-one centers across China from December 2020 to June 2021. PATIENTS: A 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. INTERVENTIONS: One 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 RESULTS: Of 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). CONCLUSIONS: Ciprofol was well tolerated, with a noninferior sedation profile to propofol in Chinese ICU patients undergoing MV for a period of 6–24 hours. |
format | Online Article Text |
id | pubmed-10497206 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-104972062023-09-13 Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial Liu, Yongjun Peng, Zhiyong Liu, Songqiao Yu, Xiangyou Zhu, Duming Zhang, Linlin Wen, Jianli An, Youzhong Zhan, Liying Wang, Xiaochuang Kang, Yan Pan, Aijun Yan, Jing Zhang, Lina Liu, Fengming Zeng, Jun Lin, Qinhan Sun, Renhua Yu, Jiangquan Wang, Huaxue Yao, Li Chen, Chuanxi Liu, Ning Nie, Yao Lyu, Jie Wu, Kun Wu, Jianfeng Liu, Xiao Guan, Xiangdong Crit Care Med Clinical Investigations OBJECTIVES: To determine the effectiveness and safety of ciprofol for sedating patients in ICUs who required mechanical ventilation (MV). DESIGN: A multicenter, single-blind, randomized, noninferiority trial. SETTING: Twenty-one centers across China from December 2020 to June 2021. PATIENTS: A 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. INTERVENTIONS: One 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 RESULTS: Of 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). CONCLUSIONS: Ciprofol was well tolerated, with a noninferior sedation profile to propofol in Chinese ICU patients undergoing MV for a period of 6–24 hours. Lippincott Williams & Wilkins 2023-06-05 2023-10 /pmc/articles/PMC10497206/ /pubmed/37272947 http://dx.doi.org/10.1097/CCM.0000000000005920 Text en 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. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | Clinical Investigations Liu, Yongjun Peng, Zhiyong Liu, Songqiao Yu, Xiangyou Zhu, Duming Zhang, Linlin Wen, Jianli An, Youzhong Zhan, Liying Wang, Xiaochuang Kang, Yan Pan, Aijun Yan, Jing Zhang, Lina Liu, Fengming Zeng, Jun Lin, Qinhan Sun, Renhua Yu, Jiangquan Wang, Huaxue Yao, Li Chen, Chuanxi Liu, Ning Nie, Yao Lyu, Jie Wu, Kun Wu, Jianfeng Liu, Xiao Guan, Xiangdong Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial |
title | Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial |
title_full | Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial |
title_fullStr | Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial |
title_full_unstemmed | Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial |
title_short | Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial |
title_sort | efficacy and safety of ciprofol sedation in icu patients undergoing mechanical ventilation: a multicenter, single-blind, randomized, noninferiority trial |
topic | Clinical Investigations |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10497206/ https://www.ncbi.nlm.nih.gov/pubmed/37272947 http://dx.doi.org/10.1097/CCM.0000000000005920 |
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