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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Respiratory Adverse Events During Anesthesia — From the start of anesthesia induction until the end of the procedure (gastroscopy withdrawal).
  Respiratory adverse events are defined as the occurrence of any of the following during the anesthesia period: hypoxemia (SpO₂ \< 92% lasting ≥30 seconds), apnea, laryngospasm, and severe or persistent coughing.

Trial sites (1)

More Second Affiliated Hospital of Wenzhou Medical University trials in China

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