RecruitingNot ApplicableNCT06525584

Ketamine Infusion as a Method of Cerebral Protection in Children

Ketamine Infusion in the Postoperative Period as a Method of Cerebral Protection in Children During Surgical Correction of Congenital Heart Defects


Sponsor

Kemerovo State Medical University

Enrollment

196 participants

Start Date

Nov 5, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 MonthMax Age: 5 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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.

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Interventions

DRUGKetamine Hcl 50Mg/Ml Inj

ketamine infusion at a dose of 0.1 mg/kg/hour for 16 hours

DRUGKetamine Hcl 50Mg/Ml Inj

ketamine infusion at a dose of 0.3 mg/kg/hour for 16 hours

OTHERControl

Without ketamine


Locations(1)

Artem Ivkin

Kemerovo, Please Select, Russia

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NCT06525584


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