Status:
RECRUITING
Ketamine Infusion as a Method of Cerebral Protection in Children
Lead Sponsor:
Kemerovo State Medical University
Conditions:
Brain Injuries
Eligibility:
All Genders
1-5 years
Phase:
NA
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 he...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06525584
Start Date
November 5 2023
End Date
December 1 2025
Last Update
July 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Artem Ivkin
Kemerovo, Please Select, Russia, 650066