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Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol
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. Prev...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9868613/ https://www.ncbi.nlm.nih.gov/pubmed/36698817 http://dx.doi.org/10.3389/fmed.2022.1024762 |
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author | 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 |
author_facet | 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 |
author_sort | Liu, Guo Liang |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9868613 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-98686132023-01-24 Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol 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 Front Med (Lausanne) Medicine 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. Frontiers Media S.A. 2023-01-09 /pmc/articles/PMC9868613/ /pubmed/36698817 http://dx.doi.org/10.3389/fmed.2022.1024762 Text en Copyright © 2023 Liu, Wu, Ge, Zhou, Cui, Gao, Sun, Yu, Liu and Liu. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine 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 Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol |
title | Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol |
title_full | Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol |
title_fullStr | Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol |
title_full_unstemmed | Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol |
title_short | Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol |
title_sort | efficacy and safety of ciprofol for agitation and delirium in the icu: a multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9868613/ https://www.ncbi.nlm.nih.gov/pubmed/36698817 http://dx.doi.org/10.3389/fmed.2022.1024762 |
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