Study of Remimazolam Sedation Compared to Propofol in Adults on Mechanical Ventilation in the ICU

What this Trial Is About

Researchers are evaluating the effects of remimazolam sedation compared to propofol in patients who are mechanically ventilated in the intensive care unit ICU. Mechanical ventilation is a critical support for patients with respiratory failure but can cause discomfort and complications that require sedation. This study aims to assess how remimazolam, a new ultra-short-acting benzodiazepine sedative, impacts outcomes in these ICU patients, given its rapid onset, quick metabolism, and mild cardiorespiratory effects. Participants will be randomly assigned to receive either remimazolam or propofol sedation. Those in the remimazolam group will receive a loading dose followed by a continuous intravenous infusion with dose adjustments to maintain a target sedation level. The propofol group will receive an initial dose followed by continuous infusion with dose adjustments to reach the same sedation target. The study is a single-center, prospective, randomized controlled pilot trial designed to compare these two sedatives in mechanically ventilated ICU patients. During the study, patient sedation levels will be monitored using the Richmond Agitation-Sedation Scale RASS to maintain a target sedation depth. Researchers will evaluate outcomes including the number of ventilator-free days within 28 days, incidence of delirium, shock-free days, ICU and hospital length of stay, and mortality at 28 days. The study includes thorough monitoring of vital signs and patient safety to assess the effects of the sedatives over the course of treatment.

Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU