AUTHOR=Yang Xiaobo , Tang Yun , Du Ruofei , Yu Yuan , Xu Jiqian , Zhang Jiancheng , Liu Hong , Zou Xiaojing , Ren Lehao , Yuan Shiying , Shang You 

TITLE=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

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 14 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1139872

DOI=10.3389/fphar.2023.1139872

ISSN=1663-9812

ABSTRACT=<p><bold>Background:</bold> 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.</p><p><bold>Methods and analysis:</bold> 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.</p><p><bold>Clinical trial registration number:</bold><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT05555667" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov/ct2/show/NCT05555667</ext-link>.</p>