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Published on: September 24, 2020
Remimazolam Versus Midazolam for Sedation in Mechanically Ventilated Patients with Severe Pneumonia: A Randomized
Haobo Kong1, Jingjing Pan1, Min Liang2
1Department of Respiratory Intensive Care Unit, Anhui Chest Hospital, Hefei City, China.
Abstract:
PurposePatients 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.MethodsThis 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.ResultsBaseline 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).ConclusionRemimazolam 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.
Insights
Remimazolam demonstrated comparable sedation efficacy and safety to midazolam in severe pneumonia patients requiring mechanical ventilation. This novel ultra-short-acting benzodiazepine offers a viable alternative for ICU sedation, with similar hemodynamic stability and no increased adverse events.
Area of Science:
- Intensive Care Medicine
- Pharmacology
- Respiratory Medicine
Background:
- Severe pneumonia in the ICU often necessitates mechanical ventilation and sedation.
- Midazolam, a common sedative, has limitations including prolonged sedation and drug accumulation.
- Remimazolam besylate is a novel ultra-short-acting benzodiazepine with potential efficacy and safety advantages.
Purpose of the Study:
- To compare the efficacy and safety of remimazolam versus midazolam for sedation in mechanically ventilated patients with severe pneumonia.
- To evaluate the proportion of time within the target Richmond Agitation-Sedation Scale (RASS) range.
- To assess secondary outcomes including hemodynamic parameters, oxygenation, and clinical outcomes.
Main Methods:
- A single-center, prospective, randomized controlled trial involving 68 adults with severe pneumonia requiring invasive mechanical ventilation.
- Patients were randomized to receive either remimazolam or midazolam, both with remifentanil for analgesia.
- The primary outcome was the percentage of time within the target RASS score (-3 to 0) over the first 72 hours.
Main Results:
- Both remimazolam and midazolam achieved 100% median time within the target RASS range, indicating comparable efficacy.
- No significant differences were found in hemodynamic parameters, oxygen saturation, duration of mechanical ventilation, or ventilator-free days.
- The 28-day mortality rates were 50% for remimazolam and 29.4% for midazolam (p=0.068).
Conclusions:
- Remimazolam offers comparable sedation efficacy and safety to midazolam in mechanically ventilated severe pneumonia patients.
- It demonstrated similar hemodynamic stability and did not increase adverse events.
- Remimazolam presents a feasible alternative for sedation in this critical patient population.
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