ClinicalTrials.gg
RecruitingNCT06525584Updated Aug 17, 2026

Ketamine Infusion as a Method of Cerebral Protection in Children

An interventional study of Ketamine Hcl 50Mg/Ml Inj and Ketamine Hcl 50Mg/Ml Inj in Brain Injuries, sponsored by Kemerovo State Medical University. Recruiting at 1 site in Russia. Open to participants aged 1 Month to 5 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Kemerovo State Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2023, registered Jul 2024).
  • Started Nov 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
1 Month to 5 Years
Sex
All
01

Study summary

The study is devoted to the use of ketamine infusion in a subanesthetic dose in the postoperative period in children after surgical correction of congenital heart defects in children.

Read the detailed description

The study will examine the safety and effectiveness for neuroprotection of subanesthetic doses of ketamine in the postoperative period in children undergoing operations to correct septal congenital heart defects using cardiopulmonary bypass.

02

Conditions studied

  • Brain Injuries

Browse trials for

03

In context

Brain Injuries

946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.

This study's planned enrollment of 196 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Kemerovo State Medical University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for participation in the study signed by the child's legal representative

Exclusion criteria

Exclusion Criteria:

  • lack of of the patient and parents to participate in the study,
  • emergency and urgent surgical interventions;
  • the presence of 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 diseases;
  • the presence of malignant neoplasms;
  • surgical complications in the postoperative period.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
196 participants (estimated)

Study arms

  • Experimental
    Ketamine 1

    Drug: Ketamine Hcl 50Mg/Ml Inj

  • Experimental
    Ketamine 3

    Drug: Ketamine Hcl 50Mg/Ml Inj

  • Placebo comparator
    Control

    Other: Control

Interventions

  • DrugKetamine Hcl 50Mg/Ml Inj

    Drug page: Ketamine

    ketamine infusion at a dose of 0.1 mg/kg/hour for 16 hours

  • DrugKetamine Hcl 50Mg/Ml Inj

    Drug page: Ketamine

    ketamine infusion at a dose of 0.3 mg/kg/hour for 16 hours

  • OtherControl

    Without ketamine

06

What researchers measure

Primary outcomes

  1. Biomarkers

    monitoring the concentration of markers of brain damage at several control points

    Time frame: 16 hours after operation

07

Study locations

1 of 1 sites recruiting
  • Artem Ivkin
    Kemerovo, Please Select 650066, Russia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06525584
Lead sponsor
Kemerovo State Medical University
Responsible party
Evgeny Grigoryev (Head of the Department of Anesthesiology, Kemerovo State Medical University) — Principal investigator
First posted
Jul 29, 2024
Start date
Nov 5, 2023
Primary completion
Dec 30, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Aug 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ketamine

Start the discussion