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Can a common anesthetic protect young brains during heart surgery?

NCT ID NCT06525584

Disease control Sponsor: Kemerovo State Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial asks whether giving children a low-dose ketamine infusion after heart surgery can protect their brains from damage. Children aged 1 to 60 months undergoing surgery for certain congenital heart defects will receive either ketamine at one of two doses or no ketamine. Researchers will monitor blood markers of brain injury at several points to see if ketamine makes a difference.

What this could mean

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

Active substance
ketamine infusion at a low dose for 16 hours after surgery
What this could lead to
If it works, this could point toward a simple way to reduce brain injury in children after heart surgery, potentially improving their recovery and long-term development.
What could go wrong
This is an early-stage trial, and the results may not show a clear benefit. Ketamine can have side effects, and the study is limited to a specific group of children and heart defects.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 196 people

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

Started

Nov 2023

Expected to finish

Dec 2028

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 5 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: * age from 1 to 60 months * body weight from 3.5 to 20 kg * planned surgical intervention to correct a congenital heart defect (atrial or ventricular septal defect) with CPBё * the presence of informed consent for participation in the study signed by the child's legal representative Exclusion Criteria: * lack of informed consent of the patient and parents to participate in the study, * emergency and urgent surgical interventions; * the presence of clinically significant anemia; * hypo-thermic during operation, episodes of desaturation in the perioperative period; * the presence of another congenital heart diseases besides the atrial or ventricular septal defect, as well as their combination; * a history of central nervous system diseases; * an installed pacemaker; * hemodynamic instability requiring preoperative pharmacological and/or mechanical support; * any episodes of cerebrovascular accidents in the history or periop-erative period; * the presence of a patient with severe concomitant diseases that worsen mental and somatic conditio; * acute infection and exacerbation of chronic infection in the perioperative period; * concomitant autoimmune diseases; * the presence of malignant neoplasms; * surgical complications in the postoperative period.

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Conditions

The condition(s) this trial relates to.

atrial septal defect brain injury ventricular septal defect

As listed by the trial registrant

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

Brain injuries

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

  • Artem Ivkin

    RECRUITING

    Kemerovo, Please Select, 650066, Russia

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