A Comparative Study on the Incidence of Respiratory Adverse Events Between Esketamine Combined With Remazolam and Traditional Propofol in Pediatric Gastroscopy
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Respiratory Adverse Events During Anesthesia
Study Overview
Brief 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.
Detailed Description
Children scheduled for elective gastroscopy under general anesthesia were randomly allocated into two groups: the RA group (Remimazolam Besylate + Esketamine), consisting of 60 cases, and the PF group (Propofol + Fentanyl), also consisting of 60 cases. The induction doses for the RA group were: Remimazolam Besylate 0.65 mg/kg + Esketamine 0.5 mg/kg. The induction doses for the PF group were: Propofol 3 mg/kg + Fentanyl 2 μg/kg.
In the RA group, Esketamine 0.5 mg/kg was administered as a single intravenous bolus over 10 seconds. 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, Remimazolam Besylate 0.65 mg/kg was administered intravenously over 15 seconds in the RA group, while Propofol 3 mg/kg was administered intravenously over 15 seconds in the PF group. Gastroscopy commenced once the child's eyelash reflex disappeared and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score was ≤1.
The following parameters were recorded: the time from intravenous induction drug administration to loss of consciousness; the incidence of respiratory adverse events during anesthesia (defined as SpO₂ <92% lasting ≥30 seconds, apnea, laryngospasm, or severe/persistent coughing); the success rate of intravenous anesthetic sedation; total gastroscopy procedure time; time to emergence from anesthesia; the incidence of postoperative agitation; MOAA/S scores; and vital signs including heart rate, blood pressure, and pulse oxygen saturation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Arms & Interventions
Group PF
Propofol 3 mg/kg + Fentanyl 2 μg/kg.
Intervention: Fentanyl and Propofol (Drug)
Group RA
Remimazolam Besylate 0.65 mg/kg + Esketamine 0.5 mg/kg.
Intervention: Esketamine and remimazolam (Drug)
Outcomes
Primary Outcomes
Respiratory Adverse Events During Anesthesia
Time Frame: 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.
Secondary Outcomes
- Success Rate of Intravenous Sedation(Assessed at the time of anesthesia induction (immediately after initial dose administration).)
- Success Rate of Gastroscopy Completion(From gastroscope insertion until its withdrawal (entire procedure duration).)
- Emergence delirium(Within up to 15-30 minutes after child's first eye opening in the postoperative period)
- Awakening time(From the withdrawal of the gastroscope (end of procedure) until the patient's first spontaneous eye-opening, assessed immediately during the post-anesthesia recovery period.)