ED50 and ED95 of remimazolam for loss of consciousness in young children: a dose-finding study for induction of anaesthesia.

Summary

In a 120-child, age-stratified dose-finding study using a biased-coin up-and-down design, the investigators estimated ED50/ED95 for remimazolam to induce loss of consciousness. Results support single-bolus induction dosing around 0.45–0.60 mg/kg across pediatric age groups, with predefined monitoring of hemodynamic and respiratory safety.

Key Findings

• Biased-coin up-and-down design in 120 children (1–12 years) estimated ED50/ED95 for remimazolam-induced loss of consciousness.
• Findings support single-bolus induction dosing around 0.45–0.60 mg/kg across pediatric age groups.
• Secondary outcomes included predefined surveillance for hypotension, respiratory depression, and adverse events.

Clinical Implications

Supports adopting approximately 0.45–0.60 mg/kg remimazolam as a starting bolus for pediatric induction, with vigilant monitoring for hypotension and respiratory depression.

Limitations

• Abstract truncation limits visibility of precise ED50/ED95 values and safety event rates.
• Single-bolus pharmacodynamics assessed; maintenance dosing and recovery profiles not addressed.

Future Directions

Confirm ED50/ED95 in multicenter settings, define maintenance strategies and recovery profiles, and compare against standard agents in randomized trials.