Comparing Remimazolam and Midazolam for Sedation in Critically Ill Adults on Mechanical Ventilation A Multicenter, Single-Blind Randomized Trial

What this Trial Is About

Researchers are evaluating the effects of remimazolam compared with midazolam on sedation and mechanical ventilation duration in critically ill patients who require mechanical ventilation. This randomized controlled trial includes patients aged 18 to 80 years who are mechanically ventilated within 48 hours of ICU admission and expected to remain in ICU for more than 72 hours. The study aims to determine if remimazolam can reduce the duration of mechanical ventilation compared to midazolam in these severe patients. Participants are randomly assigned to one of two groups. One group receives remimazolam starting with an intravenous bolus dose of 0.1 to 0.3 mgkg over one minute, followed by a maintenance infusion of 0.1 to 0.25 mgkghour, with doses adjusted according to sedation levels measured by the Richmond Agitation Sedation Scale RASS. The other group receives midazolam with an initial bolus dose of 0.01 to 0.05 mgkg, followed by a maintenance dose of 0.02 to 0.1 mgkghour, also adjusted based on RASS scores. Nonbenzodiazepine sedatives may be added if sedation goals are not met. Daily spontaneous breathing tests are performed when patients are stable to assess readiness for weaning from mechanical ventilation. Throughout the study, researchers monitor sedation success, duration of mechanical ventilation, duration of intubation, length of ICU and hospital stay, and safety outcomes such as hypotension, delirium, extubation events, and thrombus occurrence. The primary outcome is the time from enrollment to successful ventilator withdrawal, observed up to 28 days. Secondary outcomes include sedation goal completion, need for additional sedatives, anterograde amnesia, 28-day mortality, and cost assessments. Safety is closely tracked, and the total study duration per participant is up to 28 days or until successful weaning from ventilation.

Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam