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

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 a...

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Autores principales: Liu, Yongjun, Chen, Chuanxi, Liu, Ning, Tong, Li, Nie, Yao, Wu, Jianfeng, Liu, Xiao, Gao, Wei, Tang, Lei, Guan, Xiangdong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478731/
https://www.ncbi.nlm.nih.gov/pubmed/34417990
http://dx.doi.org/10.1007/s12325-021-01877-6
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author Liu, Yongjun
Chen, Chuanxi
Liu, Ning
Tong, Li
Nie, Yao
Wu, Jianfeng
Liu, Xiao
Gao, Wei
Tang, Lei
Guan, Xiangdong
author_facet Liu, Yongjun
Chen, Chuanxi
Liu, Ning
Tong, Li
Nie, Yao
Wu, Jianfeng
Liu, Xiao
Gao, Wei
Tang, Lei
Guan, Xiangdong
author_sort Liu, Yongjun
collection PubMed
description 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 ~ − 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04620031. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-021-01877-6.
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spelling pubmed-84787312021-10-08 Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol Liu, Yongjun Chen, Chuanxi Liu, Ning Tong, Li Nie, Yao Wu, Jianfeng Liu, Xiao Gao, Wei Tang, Lei Guan, Xiangdong Adv Ther Study Protocol 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 ~ − 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04620031. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-021-01877-6. Springer Healthcare 2021-08-21 2021 /pmc/articles/PMC8478731/ /pubmed/34417990 http://dx.doi.org/10.1007/s12325-021-01877-6 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Study Protocol
Liu, Yongjun
Chen, Chuanxi
Liu, Ning
Tong, Li
Nie, Yao
Wu, Jianfeng
Liu, Xiao
Gao, Wei
Tang, Lei
Guan, Xiangdong
Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol
title Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol
title_full Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol
title_fullStr Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol
title_full_unstemmed Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol
title_short Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol
title_sort efficacy and safety of ciprofol sedation in icu patients with mechanical ventilation: a clinical trial study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478731/
https://www.ncbi.nlm.nih.gov/pubmed/34417990
http://dx.doi.org/10.1007/s12325-021-01877-6
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