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Comparing Esketamine and Remazolam With Propofol for Breathing Safety in Pediatric Gastroscopy

NCT07748884 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-06

No results posted yet for this study

Summary

Gastroscopy is important for diagnosing and treating upper gastrointestinal diseases in children. To ensure the procedure is safe and smooth, most children require sedation. Compared to adults, children have more fragile airways, lower lung capacity, and poorer oxygen reserves, making them more prone to breathing difficulties and low oxygen levels during sedation.

Esketamine, a stronger form of ketamine, helps maintain heart rate and blood pressure and may reduce breathing-related risks. Remimazolam, a new short-acting sedative, acts quickly, allows faster recovery, and has a better safety profile than propofol-it doesn't cause breathing problems or injection pain.

The safety and effectiveness of combining remimazolam with esketamine for pediatric gastroscopy have not been well studied. This research will compare this new combination with the traditional propofol-based approach to evaluate its potential benefits and safety in children.

Conditions

  • Adverse Respiratory Events
  • Hypoxemia
  • Children
  • Gastroscopy
  • Esketamine
  • Remimazolam

Interventions

DRUG

Fentanyl and Propofol

In the PF group, Fentanyl 2 μg/kg was administered as a single intravenous bolus over 10 seconds. After a 1-minute waiting period for both groups, Propofol 3 mg/kg was administered intravenously over 15 seconds in the PF group.

DRUG

Esketamine and remimazolam

In the RA group, Esketamine 0.5 mg/kg was administered as a single intravenous bolus over 10 seconds.After a 1-minute waiting period for both groups, Remimazolam Besylate 0.65 mg/kg was administered intravenously over 15 seconds in the RA group.

Sponsors & Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Huacheng Liu, Ph.D. · Second Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT07748884 on ClinicalTrials.gov