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

NCT06061159 | Completed Phase 4

• 1 other identifier: SAHoWMU-CR2023-03-107
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric; ED95; Sedation; General Anesthesia

Keywords

remimazolam

Outcome Measures

Primary Outcomes (1)

• the time of the loss of consciousness(LOC)

  Modified Observers Assessment of Alertness/Sedation (MOAA/S) score of 1 or deeper within 1 minute, and maintained until the end of the 5-minute observation period.

  during anaesthetic induction

Secondary Outcomes (5)

• Modified observer's assessment of alertness／sedation（MOAA/S）scale

  Every 1 minutes after single intravenous bolus remimazolam

• BIS

  Every 1 minutes after single intravenous bolus remimazolam

• Recovery time

  Within up to 30 minutes after child's first eye opening in the postoperative period

• Number of children with adverse effects

  Up to 24 hours including preoperative, intraoperative, and postoperative periods

• Rate of Pediatric anesthesia emergence delirium

  Within up to 15-30 minutes after child's first eye opening in the postoperative period

Study Arms (3)

1-3years old

EXPERIMENTAL

single intravenous bolus remimazolam about 5min before general anesthesia induction

Drug: Remimazolam besylate

3-6years old

EXPERIMENTAL

single intravenous bolus remimazolam about 5min before general anesthesia induction

Drug: Remimazolam besylate

6-12years old

EXPERIMENTAL

single intravenous bolus remimazolam about 5min before general anesthesia induction

Drug: Remimazolam besylate

Interventions

Remimazolam besylate DRUG

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

Also known as: single intravenous bolus remimazolam according to biased coin design

6-12years old

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• with American Society of Anesthesiologists (ASA) physical status I or II；
• aged 1-12 years；
• children with weight for age within the normal range；
• were scheduled general anesthesia surgery

You may not qualify if:

• Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
• contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam;
• recently respiratory infection, mental disorder;
• other reasons that researchers hold it is not appropriate to participate in this trial.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Wenzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 40107902 DERIVED

Study Officials

• Huacheng Liu

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Yuhang Cai

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Leqi Dong

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: September 29, 2023
• Study Start: October 6, 2023
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

CN (1)