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

NCT ID: NCT06061159

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-06
• Study Completion Date: 2024-02-27

Brief 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.

Detailed Description

This experiment was divided into three groups based on the age of the children, namely 1-3 years old, 4-6 years old, 7-12 years old, with an initial dose of 0.2mg/kg. The time of consciousness loss in the children was evaluated after injection of ramazolam besylate to determine whether sedation had been achieved. The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the ED95 of a single intravenous injection of ramazolam in children of different age groups.

Conditions

Pediatric; ED95; Sedation; General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1-3years old

single intravenous bolus remimazolam about 5min before general anesthesia induction

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

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

3-6years old

single intravenous bolus remimazolam about 5min before general anesthesia induction

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

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

6-12years old

single intravenous bolus remimazolam about 5min before general anesthesia induction

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

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

Interventions

Remimazolam besylate

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

Intervention Type: DRUG

Remimazolam besylate

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

Intervention Type: DRUG

Other Intervention Names

single intravenous bolus remimazolam according to biased coin design; single intravenous bolus remimazolam according to biased coin design

Eligibility Criteria

Inclusion Criteria

1. with American Society of Anesthesiologists (ASA) physical status I or II；

2. aged 1-12 years；

3. children with weight for age within the normal range；

4. were scheduled general anesthesia surgery

Exclusion Criteria

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;

2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam;

3. recently respiratory infection, mental disorder;

4. other reasons that researchers hold it is not appropriate to participate in this trial.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huacheng Liu

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Wenzhou Medical University

Yuhang Cai

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Wenzhou Medical University

Leqi Dong

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Wenzhou Medical University

Locations

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

References

Cai YH, Dong LQ, Zhong JW, Lin Z, Chen CD, Zhu LB, Lin XK, Szmuk P, Liu HC. ED50 and ED95 of remimazolam for loss of consciousness in young children: a dose-finding study for induction of anaesthesia. Br J Anaesth. 2025 Jun;134(6):1709-1716. doi: 10.1016/j.bja.2025.02.004. Epub 2025 Mar 18.

Reference Type: DERIVED

PMID: 40107902 (View on PubMed)

Other Identifiers

SAHoWMU-CR2023-03-107

Identifier Type: -

Identifier Source: org_study_id