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

NCT07748884 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: SAHoWMU-CR2026-03-116
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Respiratory Events; Hypoxemia; Children; Gastroscopy; Esketamine; Remimazolam

Keywords

Adverse respiratory events; Hypoxemia; Children; gastroscopy; Esketamine; Remimazolam

Outcome Measures

Primary Outcomes (1)

• 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.

  From the start of anesthesia induction until the end of the procedure (gastroscopy withdrawal).

Secondary Outcomes (4)

• 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.

Study Arms (2)

Group PF

EXPERIMENTAL

Propofol 3 mg/kg + Fentanyl 2 μg/kg.

Drug: Fentanyl and Propofol

Group RA

EXPERIMENTAL

Remimazolam Besylate 0.65 mg/kg + Esketamine 0.5 mg/kg.

Drug: Esketamine and remimazolam

Interventions

Fentanyl and Propofol DRUG

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.

Group PF

Esketamine and remimazolam DRUG

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.

Group RA

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Wenzhou, Wenzhou, Zhejiang

Zhejiang, China

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Fentanyl; Propofol; Esketamine; remimazolam

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Huacheng Liu, Ph.D.

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huacheng Liu, Ph.D.

CONTACT

13957770577 Ext. +86; huachengliu@163.com

Yuhang Cai, M.D.

CONTACT

18815091585 Ext. +86; 838097626@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

CN (1)