Ketamine Infusion as a Method of Cerebral Protection in Children

Kemerovo State Medical University

Status: Enrolling

Conditions: Brain Injuries

Treatments: Other: Control; Drug: Ketamine Hcl 50Mg/Ml Inj

Study type: Interventional

Funder types: Other

Identifiers

NCT06525584

5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 1 month to 5 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 3 patient groups, including a placebo group

Ketamine 1

Experimental group

Treatment:

Drug: Ketamine Hcl 50Mg/Ml Inj

Drug: Ketamine Hcl 50Mg/Ml Inj

Ketamine 3

Experimental group

Treatment:

Drug: Ketamine Hcl 50Mg/Ml Inj

Drug: Ketamine Hcl 50Mg/Ml Inj

Control

Placebo Comparator group

Treatment:

Other: Control