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Which anesthesia is safer for Kids' brains? new trial to find out

NCT ID NCT07194109

Knowledge-focused Sponsor: The First Affiliated Hospital of Anhui 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare two anesthesia drugs—remimazolam and propofol—in 558 children aged 3 to 6 who are having their tonsils or adenoids removed. The main goal is to see which drug leads to better brain development 1 to 3 years after surgery. Children will be randomly assigned to receive one of the two drugs during their operation, and their thinking and memory skills will be tested later.

What this could mean

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

Active substance
remimazolam
What this could lead to
If remimazolam proves better for children's brain development after surgery, it could become a preferred anesthesia option for young kids.
What could go wrong
This is a Phase 4 study comparing two known drugs, so no major breakthrough is expected. Results may show no difference or be limited to this specific surgery and age group.

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 558 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Oct 2030

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

3 to 6 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: 3-6 years old; 2. Planned to undergo elective non-neurological, non-cardiac, and non-liver surgery under general anesthesia (abdominal surgery, orthopedic surgery, urological surgery, otolaryngological surgery, etc.); 3. Expected anesthesia duration to be more than 30 minutes; 4. ASA classification I-II; 5. BMI 14-25 kg/m2; 6. Postoperative plan not to be admitted to ICU; 7. Parents or legal guardians of the child have given informed consent; 8. Capable of communicating in Chinese. Exclusion Criteria: 1. Those who were exposed to general anesthetic drugs during infancy or in the late pregnancy of the mother; 2. Known chromosomal abnormalities or other known acquired or congenital diseases that may affect neural development, such as cerebral palsy, autism spectrum disorder or attention deficit hyperactivity disorder (ADHD), etc.; 3. Patients with severe liver dysfunction (Child-Pugh C grade); 4. Patients with severe kidney dysfunction (requiring dialysis before surgery); 5. Patients with a history of congenital heart disease requiring surgery or drug treatment; 6. Those allergic to the study drugs remimazolam or propofol; 7. Any known neural damage, such as cystic periventricular leukomalacia or grade 3 or 4 intraventricular hemorrhage; 8. Social or geographical factors that may lead to postoperative loss of follow-up; 9. Planned to undergo two surgeries within 7 days after the surgery; 10. Those currently participating in other clinical trials; 11. Those receiving special care or living in social welfare institutions or any other factors that may affect their ability to participate in the study.

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Conditions

The condition(s) this trial relates to.

adenoid hypertrophy

As listed by the trial registrant

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

Adenotonsillar hypertrophy

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.