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.
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;
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；
Parallel
Fentanyl and Propofol
DrugIn 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
DrugIn 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.
Respiratory Adverse Events During Anesthesia
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.
Success Rate of Intravenous Sedation
Success is defined as achieving a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 1 with the initial dose of the study anesthetic agent.
Success Rate of Gastroscopy Completion
Successful gastroscopy must meet all three requirements: (1) procedure completed without need for alternative sedation; (2) no more than 3 rescue sedation boluses within 5 minutes; and (3) meeting the predefined limits for number and dose of rescue boluses.
Emergence delirium
The pediatric anesthesia emergence delirium scale consists of five items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium.
Awakening time
from the end of gastroscopy to first spontaneous eye-opening
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