The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction
Status:
Recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University