Using ketamine infusion to protect the brain in children after heart surgery
Ketamine Infusion in the Postoperative Period as a Method of Cerebral Protection in Children During Surgical Correction of Congenital Heart Defects
This study tests if giving a low dose of ketamine to children after heart surgery can help protect their brains from injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 1 Month to 5 Years |
| Sex | All |
| Sponsor | Kemerovo State Medical University Academic / other |
| Locations | 1 site (Kemerovo, Please Select) |
| Trial ID | NCT06525584 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 60 months with planned surgical interventions for atrial or ventricular septal defects.
Not a fit: Patients with other congenital heart diseases, significant anemia, or a history of central nervous system diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of brain injuries in children undergoing heart surgery.
How similar studies have performed: While the use of ketamine for neuroprotection is a novel approach in this specific context, similar studies have shown promising results in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kemerovo, Please Select
- Artem Ivkin — Kemerovo, Please Select, Russia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.