Long-term sedation with remimazolam besylate versus propofol in critically ill patients during invasive mechanical ventilation : a study protocol for a multicenter randomized non-inferior trial
Copyright © 2023 Yang, Tang, Du, Yu, Xu, Zhang, Liu, Zou, Ren, Yuan and Shang..
Background: Remimazolam besylate is a novel ultra-short-acting benzodiazepine that can potentially be a safe and effective sedative in intensive care units. This study aims to assess whether remimazolam besylate is not inferior to propofol in maintaining mild-to-moderate sedation in critically ill patients receiving long-term mechanical ventilation. Methods and analysis: This is a multicenter, randomized, single-blind, propofol-controlled, non-inferiority study. Eligible patients are randomly assigned to receive remimazolam besylate or propofol in a 1:1 ratio to maintain a Richmond Agitation-Sedation Scale score between -3 and 0. When patients are under-sedated, rescue sedation of dexmedetomidine is added. The primary outcome is the percentage of time in the target sedation range. The secondary outcomes are hours free from the invasive ventilator in 7 days, successful extubation in 7 days, and weaning time, the length of intensive care unit stay, the length of hospital stay, and mortality in 28 days. Modified intention-to-treat and safety analysis is performed. Clinical trial registration number: https://clinicaltrials.gov/ct2/show/NCT05555667.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
Frontiers in pharmacology - 14(2023) vom: 15., Seite 1139872 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Yang, Xiaobo [VerfasserIn] |
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| Links: |
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| Themen: |
Intensive care |
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| Anmerkungen: |
Date Revised 15.08.2023 published: Electronic-eCollection ClinicalTrials.gov: NCT05555667 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.3389/fphar.2023.1139872 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM360762166 |
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| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a Copyright © 2023 Yang, Tang, Du, Yu, Xu, Zhang, Liu, Zou, Ren, Yuan and Shang. | ||
| 520 | |a Background: Remimazolam besylate is a novel ultra-short-acting benzodiazepine that can potentially be a safe and effective sedative in intensive care units. This study aims to assess whether remimazolam besylate is not inferior to propofol in maintaining mild-to-moderate sedation in critically ill patients receiving long-term mechanical ventilation. Methods and analysis: This is a multicenter, randomized, single-blind, propofol-controlled, non-inferiority study. Eligible patients are randomly assigned to receive remimazolam besylate or propofol in a 1:1 ratio to maintain a Richmond Agitation-Sedation Scale score between -3 and 0. When patients are under-sedated, rescue sedation of dexmedetomidine is added. The primary outcome is the percentage of time in the target sedation range. The secondary outcomes are hours free from the invasive ventilator in 7 days, successful extubation in 7 days, and weaning time, the length of intensive care unit stay, the length of hospital stay, and mortality in 28 days. Modified intention-to-treat and safety analysis is performed. Clinical trial registration number: https://clinicaltrials.gov/ct2/show/NCT05555667 | ||
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| 650 | 4 | |a remimazolam | |
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| 700 | 1 | |a Du, Ruofei |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Yuan |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Jiqian |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Jiancheng |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Hong |e verfasserin |4 aut | |
| 700 | 1 | |a Zou, Xiaojing |e verfasserin |4 aut | |
| 700 | 1 | |a Ren, Lehao |e verfasserin |4 aut | |
| 700 | 1 | |a Yuan, Shiying |e verfasserin |4 aut | |
| 700 | 1 | |a Shang, You |e verfasserin |4 aut | |
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