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Effect of Esketamine on 95% Induction Dose of Remimazolam

NCT06303037 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

  • Pediatric
  • Gastroscopy
  • ED95
  • Sedation

Interventions

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

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

  • Qiaoqiao Wang · Second Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-08-29
Completion
2024-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06303037 on ClinicalTrials.gov