Ketamine Infusion as a Method of Cerebral Protection in Children

Ketamine Infusion in the Postoperative Period as a Method of Cerebral Protection in Children During Surgical Correction of Congenital Heart Defects

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06525584

Enrollment

196

Registered

2024-07-29

Start date

2023-11-05

Completion date

2028-12-30

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

Brief 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.

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.

Interventions

DRUGKetamine Hcl 50Mg/Ml Inj

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

OTHERControl

Without ketamine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Months to 5 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Biomarkers	16 hours after operation	monitoring the concentration of markers of brain damage at several control points

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026