Ketamine Infusion as a Method of Cerebral Protection in Children
ConditionBrain Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorKemerovo State Medical University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine Hcl 50Mg/Ml Inj
Drugketamine infusion at a dose of 0.1 mg/kg/hour for 16 hours
Ketamine Hcl 50Mg/Ml Inj
Drugketamine infusion at a dose of 0.3 mg/kg/hour for 16 hours
Control
Other interventionWithout ketamine
Treatment groups
196 Participants
are divided into 3 treatment groupsGroup A: Ketamine 1Experimental treatment 1 intervention
Group B: Ketamine 3Experimental treatment 1 intervention
Group C: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Biomarkers
monitoring the concentration of markers of brain damage at several control points
Time frame
16 hours after operationSponsors and contacts
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Source ClinicalTrials.gov