Using ketamine infusion to protect the brain in children after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of subanesthetic doses of ketamine infusion in children undergoing surgical correction of congenital heart defects. The focus is on its potential neuroprotective effects during the postoperative period, particularly for those who have undergone operations involving cardiopulmonary bypass. Participants will receive either ketamine or a control treatment, and the outcomes will be assessed to determine the benefits of ketamine in preventing brain injuries.

Why it matters

Who can join: the full rules

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.

Where it's running

• Artem Ivkin
  Kemerovo, Please Select, Russia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.