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

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.

Conditions

• Pediatric
• ED95
• Sedation
• General Anesthesia

Interventions

DRUG

Remimazolam besylate

initial dose is 0.2mg/kg；adjust dosage is 0.05mg/kg

DRUG

Remimazolam besylate

initial dose is based on the findings from the school-age group；adjust dosage is 0.05mg/kg

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University

  lead OTHER

Principal Investigators

• Huacheng Liu · Second Affiliated Hospital of Wenzhou Medical University

• Yuhang Cai · Second Affiliated Hospital of Wenzhou Medical University

• Leqi Dong · Second Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-06

Primary Completion

2024-02-27

Completion

2024-02-27

Countries

• China

Study Locations