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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Injuries
• Intervention / Treatment: Drug: Ketamine Hcl 50Mg/Ml Inj; Drug: Ketamine Hcl 50Mg/Ml Inj; Other: Control

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 Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Please Select
    • Kemerovo, Please Select, Russian Federation, 650066
      • Recruiting
      • Artem Ivkin
      • Contact: Artem Ivkin; Phone Number: +79030701880; Email: ivkiaa@kemcardio.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Other: Control; Without ketamine
Experimental: Ketamine 1	Drug: Ketamine Hcl 50Mg/Ml Inj; ketamine infusion at a dose of 0.1 mg/kg/hour for 16 hours; Drug: Ketamine Hcl 50Mg/Ml Inj; ketamine infusion at a dose of 0.3 mg/kg/hour for 16 hours
Experimental: Ketamine 3	Drug: Ketamine Hcl 50Mg/Ml Inj; ketamine infusion at a dose of 0.1 mg/kg/hour for 16 hours; Drug: Ketamine Hcl 50Mg/Ml Inj; ketamine infusion at a dose of 0.3 mg/kg/hour for 16 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	monitoring the concentration of markers of brain damage at several control points	16 hours after operation

Collaborators and Investigators

• Sponsor: Kemerovo State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No