Ketamine Infusion as a Method of Cerebral Protection in Children

NCT06525584 | Recruiting DMC

• 1 other identifier: 5
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Biomarkers

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

  16 hours after operation

Study Arms (3)

Ketamine 1

EXPERIMENTAL

Drug: Ketamine Hcl 50Mg/Ml Inj

Ketamine 3

EXPERIMENTAL

Drug: Ketamine Hcl 50Mg/Ml Inj

Control

PLACEBO COMPARATOR

Other: Control

Interventions

Ketamine Hcl 50Mg/Ml Inj DRUG

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

Ketamine 1

Control OTHER

Without ketamine

Control

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kemerovo State Medical University: lead

Study Sites (1)

Artem Ivkin

Kemerovo, Please Select, 650066, Russia

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: November 5, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)