ICU sedation, delirium & recovery

Prolonged infusion of remimazolam in surgical and medical intensive care unit patients: a pilot pharmacokinetic study

J Intensive CarePublished Pharmacokinetic study

Authors' conclusion

In this preliminary study, both the surgical ICU group (approximately 24 h) and the medical ICU group (beyond 24 h) showed no evidence of time-dependent accumulation of plasma remimazolam, indicating a generally stable pharmacokinetic profile under the examined conditions.

Study context

Population
Patients requiring mechanical ventilation receiving remimazolam 0.1 mg/kg/h for ≥ 24 hcompleted the study
Participants
20 patients
Comparison
Prolonged remimazolam infusion in surgical vs medical intensive care unit (ICU) patients
  • Surgicaln = 10
  • Medical ICUn = 10
Outcome
Pharmacokinetics of remimazolam administered continuously
Follow-up
24 h
Methodological detailsopen-label, pilot
  • Open-label
  • Pilot

Main finding

As reported in the abstract

Pharmacokinetics of prolonged remimazolam infusion
GroupValuePlasma concentration at end of infusionClearanceVolume of distribution at steady stateMedian infusion duration
Surgical130.7 (95% CI 115.2–146.1) ng/mL130.7 ng/mL54.3 L/h (95% CI 47.6-61.8)284 L (95% CI 215-376)24.0 h
Medical ICU134.3 (95% CI 98.7–170.0) ng/mL134.3 ng/mL55.6 L/h (95% CI 42.8-72.1)316 L (95% CI 142-707)102.0 h

Value

Surgical130.7 (95% CI 115.2–146.1) ng/mL
Medical ICU134.3 (95% CI 98.7–170.0) ng/mL

Plasma concentration at end of infusion

Surgical130.7 ng/mL
Medical ICU134.3 ng/mL

Clearance

Surgical54.3 L/h (95% CI 47.6-61.8)
Medical ICU55.6 L/h (95% CI 42.8-72.1)

Volume of distribution at steady state

Surgical284 L (95% CI 215-376)
Medical ICU316 L (95% CI 142-707)

Median infusion duration

Surgical24.0 h
Medical ICU102.0 h
  • Surgical vs Medical ICU: P = 0.856 — no statistically significant difference
  • Surgical vs Medical ICU: P = 0.780 — no statistically significant difference
Steady-state plasma concentration intrasubject variability (modest)
4.46-32.73%
Steady-state plasma concentration intersubject variability (moderate)
16.45-31.71%

Original publication

Prolonged infusion of remimazolam in surgical and medical intensive care unit patients: a pilot pharmacokinetic study. J Intensive Care. Published 11 December 2025. doi:10.1186/s40560-025-00840-9

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