Trial reportAnesthesiology2025
Pharmacokinetics and Pharmacodynamics of Remimazolam for Procedural Sedation in Children and Adolescents.
Trial report in Anesthesiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Remimazolam in pediatric anesthesia: a systematic review for clinical decision-making.Frontiers in pediatrics · 2025Pooled it
- Remimazolam ED95 for Preoperative Sedation in Children with Obstructive Sleep Apnea, with Obesity or a Reference-Range BMI: A Biased-Coin Dose-Finding Study.Drug design, development and therapy · 2026Trial
- Pediatric sedation is not adult sedation in small: lessons from a PK/PD analysis of remimazolam.Translational pediatrics · 2026Article
- Remimazolam in pediatric sedation and anesthesia: current perspectives and clinical considerations.Journal of intensive care · 2026Review
- Comparative long-term sedation efficacy of remimazolam vs propofol in malignant patients with mechanical ventilation: an exploratory non-inferiority randomized study.Scientific reports · 2026Article
- Advantages of Remimazolam in Pediatric Anesthesia: A Narrative Review.Children (Basel, Switzerland) · 2026Review
- Comparative analysis of esketamine versus remimazolam in adult and pediatric surgical patients: a multimodal monitoring evaluation.American journal of translational research · 2026Article
- Flumazenil reversal of remimazolam-induced sedation: a narrative review of safety, pharmacokinetics, and clinical considerations.Frontiers in medicine · 2026Review
- Effect of Remimazolam on Postoperative Delirium in Elderly Surgical Patients: A Critical Review of Pharmacological Mechanisms and Clinical Evidence.Drug design, development and therapy · 2026Review
- Optimal Dosing Strategies for Remimazolam Across Diverse Patient Populations: A Clinical Narrative Review.Drug design, development and therapy · 2026Review
- Age-Stratified EDDrug design, development and therapy · 2026Article
- Research Progress on the Clinical Application of Remimazolam Outside the Operating Room: A Review of Pharmacological Characteristics, Clinical Effects, and Safety.Clinical pharmacology : advances and applications · 2025Review
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRemimazolam is not approved for use in pediatric patients. The pharmacokinetics of remimazolam have been reported to be similar to those of adult patients after scaling for body size. This article reports on the pharmacokinetics and pharmacodynamics of pediatric patients aged 6 to 18 yr and a subsequent model-based optimization of the used dosing regimen.
methodsThirty-one patients were included in the trial and stratified across four treatment arms: bolus administration, infusion, bolus plus fentanyl, or infusion plus fentanyl. The University of Michigan (Ann Arbor, Michigan) Sedation Scale (UMSS) was used to assess the depth of sedation. Blood samples were drawn to measure the concentrations of remimazolam and its metabolite CNS7054. Population pharmacokinetic pharmacodynamic modeling was performed in NONMEM (GloboMax LLC, USA).
resultsA population pharmacokinetic model was developed for remimazolam and CNS7054. The elimination clearance of remimazolam was 0.70 l · min -1 · 70 kg -1 . A proportional odds model combined with a simplified Minto model described the observed UMSS well. The EC50 of remimazolam for a UMSS score of 3 or greater was 777 ng · ml -1 in the absence of fentanyl, and decreased to 655, 533, and 287 ng/ml for concomitant fentanyl steady state concentrations of 1, 2, or 4 ng · ml -1 , respectively. Simulations confirmed that the studied dosing regimen resulted in 9.2 to 22.0% of patients not reaching a UMSS score of 3 or greater at the end of the induction. Model-based optimization resulted in higher per-kilogram dosages and the removal of the maximum allowable dose. Simulations indicated that the percentage of patients achieving a UMSS score of 3 or greater can be expected to be high (88 to 97%).
conclusionsThis study has shown that the pharmacokinetics of remimazolam are likely different between children 6 yr or older and adults (after correcting for size). In addition, the exposure-response relationship shows that to effectively use remimazolam for procedural sedation in children 6 yr or older, the dosing regimen should be modified to allow for higher remimazolam exposures.
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