ArticleJournal of thoracic disease2026
Sedation with remimazolam besylate versus midazolam in acute respiratory distress syndrome patients supported by venovenous extracorporeal membrane oxygenation: a study protocol for a multicenter prospective randomized trial.
Article in Journal of thoracic disease, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
13 authors.
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Abstract
Background: Remimazolam besylate is a novel ultra-short-acting benzodiazepine which offers rapid sedation onset, predictable metabolism, and reduced hemodynamic instability compared to traditional agents. This trial aims to evaluate the sedation efficacy and safety of remimazolam besylate compared to midazolam in acute respiratory distress syndrome (ARDS) patients requiring venovenous extracorporeal membrane oxygenation (VV-ECMO). Methods: This is a multicenter, randomized, single-blind, pilot trial that enrolls adults with ARDS on VV-ECMO. Patients will be randomized 1:1 to protocol-directed sedation with either remimazolam besylate or midazolam, targeting a Richmond Agitation-Sedation Scale (RASS) score of -4. A standardized rescue sedation protocol with dexmedetomidine is predefined. The primary outcome is the percentage of time within the target sedation range (TTR) without rescue sedation. Secondary outcomes are difference in time to awakening between the two groups, ECMO duration, 28-day mortality, delirium incidence, and comprehensive safety evaluation, analyzed using modified intention-to-treat and safety analyses. Discussion: This multicenter, randomized controlled pilot trial evaluates the safety and efficacy of remimazolam besylate versus midazolam for sedation in ARDS patients supported by VV-ECMO. As the first prospective study in this population, it aims to evaluate comparative sedation efficacy while characterizing hemodynamic stability and recovery profiles. The results are expected to offer significant evidence to guide future trials and optimize sedation practices in complex intensive care unit settings. Trial Registration: ChiCTR2500108567.
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