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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-12
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Fentanyl and Propofol
  • Esketamine and remimazolam

Treatment groups

120 Participants
are divided into 2 treatment groups