Ketamine Infusion as a Method of Cerebral Protection in Children

Not Applicable

Recruiting

• Conditions: Brain Injuries
• Interventions: Drug: Ketamine Hcl 50Mg/Ml Inj; Other: Control

• Registration Number: NCT06525584
• Lead Sponsor: Kemerovo State Medical University

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.

Study Timeline

• Study Start: 2023-11-05
• Status Verified: 2024-07
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 196

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine 1	Ketamine Hcl 50Mg/Ml Inj	-
Control	Control	-
Ketamine 3	Ketamine Hcl 50Mg/Ml Inj	-

Primary Outcome Measures

Name	Time	Method
Biomarkers	16 hours after operation	monitoring the concentration of markers of brain damage at several control points

Trial Locations

Locations (1)

Artem Ivkin; 🇷🇺 Kemerovo, Please Select, Russian Federation