NCT06303037

Effect of Esketamine on 95% Induction Dose of Remimazolam

Determination of the 95% Effective Dose of Remimazolam in Combination With Different Doses of Esketamine During Gastroscopy in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Accepted

Summary

As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children.

Detailed description

Children aged 3-12 who underwent gastroscopy were randomly divided into two groups: L group with Esketamine 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg ,M group with Esketamine 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg.Judging whether the sedation level of the children can meet the requirements of gastroscopy placement after injecting Remimazolam.The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the induced dose of ED95 of Remimazolam under the background of different doses of Esketamine.

Conditions

• Pediatric
• Gastroscopy
• ED95
• Sedation

Interventions

Type	Name	Description
DRUG	Remimazolam besylate and low-dose Esketamine	Esketamine was injected intravenously 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg
DRUG	Remimazolam besylate and Medium dose Esketamine	Esketamine was injected intravenously 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-08-29
• Completion: 2024-12-01
• First posted: 2024-03-12
• Last updated: 2025-02-06

Locations

1 site across 1 country: China