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Can a new sedative combo make Children's gastroscopy safer?

NCT ID NCT07748884

Symptom relief Sponsor: Second Affiliated Hospital of Wenzhou Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether a combination of esketamine and remimazolam can reduce breathing problems in children aged 6 to 12 during gastroscopy, compared to the traditional propofol-based sedation. Children have smaller airways and lower oxygen reserves, making them more prone to low oxygen levels during sedation. The study will measure how often respiratory issues like low oxygen or coughing occur, and also check how well the sedation works and how quickly children recover.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Esketamine combined with remimazolam, compared with fentanyl and propofol
What this could lead to
If this combination works, it could offer a safer sedation option for children undergoing gastroscopy, with fewer breathing complications and faster recovery.
What could go wrong
This is a single-center study with 120 children, so results may not apply broadly. The new combo might not prove safer than propofol, and any sedative carries risks like low oxygen or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 6 to 12 years, both sexes; 2. American Society of Anesthesiologists (ASA) physical status I or II; 3. Scheduled for elective gastroscopy or esophagogastroduodenoscopy (EGD) under anesthesia; 4. Preoperative oxygen saturation of 100% while breathing room air; 5. Weight within the normal range for age and gender according to the following reference values (inclusive of endpoints) Exclusion Criteria: 1. Contraindications to sedation or anesthesia, or a history of adverse events related to sedation/anesthesia； 2. Known or suspected allergy to the study drug, benzodiazepines, or their reversal agents； 3. History of respiratory disease within the past 2 weeks, or known difficult airway (modified Mallampati score III or IV)； 4. History of cardiac, hepatic, renal dysfunction, or metabolic diseases； 5. Patients with congenital diseases or other conditions that may interfere with the evaluation of efficacy outcomes.

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Conditions

The condition(s) this trial relates to.

Hypoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adverse respiratory events Children Esketamine Gastroscopy Hypoxemia Remimazolam

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Zhejiang, China

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