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Can a sedative help kids need less anesthesia?

NCT ID NCT03384563

Knowledge-focused Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study looks at whether giving children a sedative called dexmedetomidine (Precedex) can lower the amount of sevoflurane anesthesia needed during surgery. Researchers will test two different doses in 180 children aged 1 month to 3 years. The goal is to find the right balance for safer anesthesia.

What this could mean

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

Active substance
Dexmedetomidine (Precedex)
What this could lead to
If successful, this could help anesthesiologists use lower doses of sevoflurane in children, potentially reducing side effects.
What could go wrong
This is a small, early-phase study focused on measuring anesthesia depth, not on treating a disease. Results may not apply to all children or surgeries.

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 180 people

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

Started

Feb 2018

Expected to finish

Dec 2025

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

1 month to 36 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Exclusion Criteria: 1. Interstitial lung disease, chest wall disease, or bronchospastic disease with no flare-ups in the past 2 weeks of presentation 2. History of difficult intubation or ventilation 3. Airway malformation 4. Congenital heart disease 5. Cardiac arrhythmias 6. Central nervous system disease, including developmental delay, cerebral palsy, or seizure disorder 7. History of or family history of malignant hyperthermia 8. Electrolyte disorders 9. Gastrointestinal disease 10. Hepatic dysfunction 11. Renal dysfunction 12. Metabolic disease, such as diabetes 13. Obesity, defined as a body mass index greater than the 95% percentile for age 14. Preterm infant (less than 37 weeks gestational age) 15. Use of any medications (anticonvulsants, opioids, benzodiazepines, antibiotics, antihistamines drugs that induce hepatic enzymes) that may affect MAC. Inclusion Criteria All patients age 1 month- 3 years presenting for surgery.

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As listed by the trial registrant

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

Pediatric anesthesia

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

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

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