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NCT06525584
Ketamine Infusion as a Method of Cerebral Protection in Children
Conditions: Brain Injuries
Sex: All
Ages: 1 Month – 5 Years
Healthy volunteers: No
Phase: NA
Enrollment: 196
Sponsor: Kemerovo State Medical University
Location: Artem Ivkin Kemerovo Please Select
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT06525584). StuddyBuddy aggregates publicly available trial information.