ICU sedation, delirium & recovery
A phase 2 open-label pilot study of Remimazolam for sedation in critically ill patients
Authors' conclusion
Remimazolam could be useful for sedation in the ICU but deserves further investigation before routine use.
Study context
- Population
- Critically ill patients with expected duration of sedation ≥ 24 h
- Participants
- 30 patients
- Outcome
- Composite:
- Targeted sedation level without another hypnotic drug
- Hemodynamic stability (no drop in MAP ≤ 65 mmHg and no increase in norepinephrine dose ≥ 50% for more than 1 h)
- Follow-up
- First 8 h after start
Methodological detailsinvestigator-initiated, single-centre, non-randomised, open-label
- Investigator-initiated
- Single-centre
- Non-randomised
- Open-label
Main finding
As reported in the abstract
Composite:
- Targeted sedation level without another hypnotic
- Hemodynamic stability
Patients meeting the primary endpoint
14
46.7%
Secondary outcomes
Duration of infusion
- Patients receiving Remimazolam for 48 h
- 10 (33.3%)
Dose
- Patients receiving the highest dose
- 4 (13.3%)
Mortality
- Mortality rate
- 23.3%
Pharmacokinetics
- Steady plasma levels throughout the infusion and rapid elimination after dosing discontinuation
Safety
Adverse events
- Adverse Events (AEs) reported (in 23 patients)
- 54
- Serious AEs (in 8 patients)
- 11
- AEs related to Remimazolam
- 10
Original publication
A phase 2 open-label pilot study of Remimazolam for sedation in critically ill patients. Anaesth Crit Care Pain Med. Published 31 March 2025. doi:10.
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