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.
Interested in this trial?
Get notified about updates and connect with the research team.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06525584
Related Trials
The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms
NCT066075231 location
Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma
NCT069325881 location
The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients
NCT0500892611 locations
Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)
NCT064131732 locations
Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions
NCT025922911 location