Comparing Esketamine and Remazolam With Propofol for Breathing Safety in Pediatric Gastroscopy
Starting soon · Phase 4
Conditions studied: Adverse Respiratory Events, Hypoxemia, Children, Gastroscopy, Esketamine, Remimazolam
In brief
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.
Key facts
- Study ID
- NCT07748884
- Run by
- Second Affiliated Hospital of Wenzhou Medical University
- People needed
- 120
- Starts
- 2026-08-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 6 to 12 years, both sexes;
- American Society of Anesthesiologists (ASA) physical status I or II;
- Scheduled for elective gastroscopy or esophagogastroduodenoscopy (EGD) under anesthesia;
- Preoperative oxygen saturation of 100% while breathing room air;
- Weight within the normal range for age and gender according to the following reference values (inclusive of endpoints)
You may not qualify if…
- Contraindications to sedation or anesthesia, or a history of adverse events related to sedation/anesthesia；
- Known or suspected allergy to the study drug, benzodiazepines, or their reversal agents；
- History of respiratory disease within the past 2 weeks, or known difficult airway (modified Mallampati score III or IV)；
- History of cardiac, hepatic, renal dysfunction, or metabolic diseases；
- Patients with congenital diseases or other conditions that may interfere with the evaluation of efficacy outcomes.
Where it is running
- The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Wenzhou, Wenzhou, Zhejiang — Zhejiang, China
Full record on ClinicalTrials.gov
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