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NOT YET RECRUITING
NCT07748884
PHASE4

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

Sponsor: Second Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

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.

Official title: A Comparative Study on the Incidence of Respiratory Adverse Events Between Esketamine Combined With Remazolam and Traditional Propofol in Pediatric Gastroscopy

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-08

Completion Date

2026-12

Last Updated

2026-08-06

Healthy Volunteers

No

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.

Locations (1)

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

Zhejiang, China