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NCT06061159

The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction

Completed Phase 4 Last updated 7 February 2025
What this trial tests

Phase 4 trial testing Remimazolam besylate in Pediatric in 120 participants. Completed in 27 February 2024.

Timeline
6 October 2023
Primary endpoint
27 February 2024
27 February 2024

Quick facts

Lead sponsorSecond Affiliated Hospital of Wenzhou Medical University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment120
Start date6 October 2023
Primary completion27 February 2024
Estimated completion27 February 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Who can join

Adults 1 to 12, any sex, with Pediatric or ED95. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Due to the incomplete development of systems and low pain thresholds in the pediatric population, good general anesthesia is required during the perioperative period to ensure the smooth progress of the surgery.Propofol is often used for anesthesia induction in clinical work, which can achieve good anesthesia effects. However, this drug has obvious injection pain and is prone to significant inhibition of blood circulation, and may even lead to adverse conditions such as respiratory depression in children. For the pediatric population, maintaining appropriate anesthesia depth and stable circulation during the induction period of general anesthesia has always been a focus of attention and research by anesthesiologists.Remimazolam besylate is a new type of water-soluble ultra short acting benzodiazepine drug that is hydrolyzed and metabolized by plasma esterase in the body, independent of liver and kidney function, and the metabolite zolam propionic acid has no pharmacological activity; Rapid onset and failure, short sedation recovery time; Has little impact on respiration and circulation; And there is no injection pain.Remazolam besylate is highly suitable for children due to its characteristics, and some studies have demonstrated the safety of intravenous injection of Remazolam besylate. However, there is limited research on its dosage exploration, which to some extent limits its clinical application in children.This study aims to explore the 95% effective dose (ED95) of single intravenous injection of remidazolam besylate in children of different age groups, providing a theoretical basis for the use of remidazolam besylate in pediatric anesthesia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. ED50 and ED95 of remimazolam for loss of consciousness in young children: a dose-finding study for induction of anaesthesia.
    Cai YH, Dong LQ, Zhong JW, Lin Z, et al · · 2025 · cited 13× · PMID 40107902 · DOI 10.1016/j.bja.2025.02.004

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Other Second Affiliated Hospital of Wenzhou Medical University trials

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