Remimazolam Versus Midazolam for Sedation in Mechanically Ventilated Patients with Severe Pneumonia: A Randomized Controlled Trial

Purpose Patients with severe pneumonia in the intensive care unit often require mechanical ventilation and sedation. Midazolam, a common sedative, is limited by prolonged sedation and accumulation. Remimazolam besylate, a novel ultra-short-acting benzodiazepine, offers efficacy and safety. This study compared remimazolam and midazolam for sedation in mechanically ventilated patients with severe pneumonia. Methods This single-center, prospective, randomized controlled trial enrolled 68 adults with severe pneumonia requiring invasive mechanical ventilation, targeting a Richmond Agitation–Sedation Scale (RASS) score of −3 to 0. Patients were randomized 1:1 to receive either remimazolam (initial dose 0.2 mg/kg/h) or midazolam (initial dose 0.02 mg/kg/h), all receiving remifentanil for analgesia. The primary outcome was the proportion of time spent within the target RASS range without rescue sedation during the first 72 h after randomization. Secondary outcomes included hemodynamic parameters, oxygen saturation, duration of mechanical ventilation, ventilator-free days at day 28 +(VFD-28), and 28-day mortality. Results Baseline characteristics were comparable, and the median percentage of time within the target RASS range was 100% (p = 0.989) for both groups. Rescue sedation was required in 11.8% of the remimazolam group and 17.6% of the midazolam group (p = 0.734). No significant differences were observed in mean arterial pressure, heart rate, oxygen saturation, duration of mechanical ventilation, ventilator-free days at day 28, or the incidence of hypotension or bradycardia. The 28-day mortality rates were 50% in the remimazolam and 29.4% in the midazolam groups (p = 0.068). Conclusion Remimazolam provided sedation efficacy and safety comparable to midazolam in mechanically ventilated patients with severe pneumonia, with similar hemodynamic stability and no increase in adverse events, suggesting that it may be a feasible alternative for sedation in mechanically ventilated patients with severe pneumonia.