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Published on: December 6, 2016

Age-Stratified ED9 5 of Remimazolam Tosilate for Moderate Sedation in Pediatric Patients: A Biased Coin Design Study

Bingqing Zhu1, Wenjun Meng1, Kunyun Pan1

  • 1Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.

Drug Design, Development and Therapy
|June 15, 2026
PubMed

Insights

This study determined age-specific effective doses of remimazolam tosilate for moderate sedation in children. Toddlers required higher doses, and closer monitoring for bradycardia is advised.

Area of Science:

  • Pediatric Anesthesiology
  • Pharmacology
  • Clinical Trials

Background:

  • Pediatric sedation presents challenges due to age-related physiological differences.
  • Establishing safe and effective sedative doses for children is crucial.

Purpose of the Study:

  • To determine the age-stratified 95% effective dose (ED95) of remimazolam tosilate for moderate sedation in pediatric patients.
  • To identify age-specific dosing guidelines for remimazolam tosilate in children aged 1-12 years.

Main Methods:

  • A biased coin design up-and-down sequential method was used to determine the ED95 in three pediatric age groups (toddlers, preschoolers, school-aged children).
  • Sedation success was defined as a Modified Observer's Assessment of Alertness and Sedation (MOAA/S) score ≤ 3.
  • Doses were adjusted based on patient response, and perioperative variables and adverse events were monitored.

Main Results:

  • The estimated ED95 of remimazolam tosilate was 0.415 mg·kg⁻¹ in toddlers, 0.389 mg·kg⁻¹ in preschoolers, and 0.362 mg·kg⁻¹ in school-aged children.
  • Toddlers exhibited the longest median wake-up time (32.5 min).
  • Adverse events were infrequent, with bradycardia and oxygen desaturation observed in 5.8% of patients.

Conclusions:

  • Age-specific ED95 reference doses for remimazolam tosilate in pediatric moderate sedation were established.
  • While remimazolam has a favorable safety profile, individualized dose titration is essential.
  • Particular attention and closer monitoring are warranted for toddlers due to a higher incidence of bradycardia.
Abstract

Keywords:
95% effective dosechildrenremimazolamsedation

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