Actively Recruiting
Ketamine Infusion in the Postoperative Period as a Method of Cerebral Protection in Children During Surgical Correction of Congenital Heart Defects
Led by Kemerovo State Medical University · Updated on 2024-07-29
196
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and neuroprotective effectiveness of subanesthetic doses of ketamine given after surgery in children who have congenital heart defects. The focus is on children undergoing operations to repair atrial or ventricular septal defects using cardiopulmonary bypass. The study aims to understand how ketamine infusion may protect the brain during the postoperative period in this young population. Participants are divided into groups receiving either low-dose ketamine infusion at 0.1 mg/kg/hour, higher dose ketamine at 0.3 mg/kg/hour, or no ketamine (control group). The ketamine is infused continuously for 16 hours after surgery. The study uses a randomized design with single masking to compare these different approaches. During the study, children will be closely monitored with blood tests to measure biomarkers 16 hours after surgery to assess brain injury. The research team will also evaluate safety and any complications during the postoperative period. Participation involves medical assessments and monitoring in the hospital with follow-up as needed. The study includes children aged 1 month to 5 years and lasts throughout the postoperative recovery phase.
CONDITIONS
Brief Title
Ketamine Infusion as a Method of Cerebral Protection in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 1 to 60 months
- Body weight from 3.5 to 20 kg
- Planned surgery to correct atrial or ventricular septal defect with cardiopulmonary bypass
- Informed consent signed by the child's legal representative
You will not qualify if you...
- Lack of informed consent from patient and parents
- Emergency or urgent surgical interventions
- Clinically significant anemia
- Hypothermia or desaturation episodes during operation or perioperative period
- Presence of other congenital heart diseases besides atrial or ventricular septal defect
- History of central nervous system diseases
- Installed pacemaker
- Hemodynamic instability needing preoperative pharmacological or mechanical support
- Any cerebrovascular accidents in history or perioperative period
- Severe concomitant diseases worsening mental or physical condition
- Acute infection or exacerbation of chronic infection in perioperative period
- Concomitant autoimmune diseases
- Presence of malignant tumors
- Surgical complications in postoperative period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 hours
Participants receive a ketamine infusion at a dose of 0.1 mg/kg/hour or 0.3 mg/kg/hour for 16 hours after surgery, or no ketamine for the control group, to evaluate neuroprotection during the postoperative period.
1 postoperative infusion period
Trial Site Locations
Total: 1 location
1
Artem Ivkin
Kemerovo, Please Select, Russia, 650066
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here