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NCT Number: NCT06525584

Ketamine Infusion as a Method of Cerebral Protection in Children

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.

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Key information

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Artem Ivkin

Kemerovo, Please Select, 650066, Russia

Location status: Recruiting

Location contact

Artem Ivkin

CONTACT

[email protected]

+79030701880

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketamine Hcl 50Mg/Ml Inj

Drug

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

Control

Other

Without ketamine

Primary outcomes

  1. Biomarkers

    Time frame: 16 hours after operation

    monitoring the concentration of markers of brain damage at several control points

Sponsors and collaborators

Lead sponsor

Kemerovo State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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