Comparing Esketamine and Remazolam With Propofol for Breathing Safety in Pediatric Gastroscopy (NCT07748884) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Comparing Esketamine and Remazolam With Propofol for Breathing Safety in Pediatric Gastroscopy
China120 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Respiratory Adverse Events During Anesthesia
Timeframe: From the start of anesthesia induction until the end of the procedure (gastroscopy withdrawal).
Trial details
NCT IDNCT07748884
SponsorSecond Affiliated Hospital of Wenzhou Medical University