Newborn, Infant, Disease, Peri-operative Injury
Conditions
Keywords
S-100B protein, Neuron-specific Enolase
Brief summary
The purpose of this study is to assess whether peri-operative period in neonates and infants is associated with an increase in blood biomarkers, specific for neuronal injury, and to correlate them with clinical variables and sedative/analgesic agents. Patients, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. Blood samples for measurement serum concentrations of markers (S100-B and Neuron-Specific Enolase (NSE)) are drawn before surgery (baseline) and on the 1-st, 2-nd and 3-rd day after surgery. During surgery cerebral oxygenation (rSO2) monitoring is continuously applied; rSO2, hemodynamic and respiratory values are simultaneously recorded every 5 minutes. Anesthesia, pre and postoperative treatment, including analgesia and sedation, are given as per standard of care.
Detailed description
Retrospective studies have shown that surgery in infancy is associated with worse neurodevelopmental outcome, compared to general population. The reasons may be complex, and patients at risk are unknown. Brain growth and central nervous system formation are extremely active in neonates and infants. Metabolic or circulatory derangement may have negative influence on the developing brain. Disease and perioperative period, both may further put this population at risk for physiological abnormalities. Near infrared spectroscopy was shown to be a convenient method for monitoring of cerebral tissue oxygenation during surgery. The great majority of anesthetics and sedative drugs, used in perioperative period, were shown to cause neuronal apoptosis in experimental animals. Some studies found that neurological marker S-100B increased in cerebrospinal fluid and blood immediately following anesthesia in animals. Several clinical studies supported this founding in children following cardiac and general surgery. The aim of this study is to assess the dynamics of S-100B protein pre- and during 72 hours after surgery in neonates and infants aged 1-93 days, operated for abdominal/thoracic/urologic malformations/disease. As S-100B in blood may have extracranial sources, we simultaneously assess other neuronal marker Neuron-specific Enolase.
Interventions
PROCEDURECerebral near infrared spectroscopy
At the start of anesthesia on the patient's forehead two electrodes are attached the for continuous measurement of cerebral near infrared spectroscopy during surgery.
OTHERS-100B protein in serum
0,5-1 ml of blood from periferal site for determination of serum S-100B concentration.
OTHERNSE protein in serum
0,5-1 ml of blood from periferal site for determination of serum NSE concentration.
Sponsors
Research Council of Lithuania
Lithuanian University of Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 93 Days
Healthy volunteers
No
Inclusion criteria
* patients, undergoing general, thoracic, urological surgery for congenital anomalies or disease * signed written informed consent by parents/official caregivers
Exclusion criteria
* cardiac surgery * any evidence of neurological disease * sepsis * limited ability to obtain blood samples * clinically significant anemia * physical status of the patients corresponding to American Society of Anesthesiologists (ASA) class 4 and 5.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in S-100B and NSE concentrations in serum | within 24 hours and 3 days after surgery | change in S-100B and NSE concentrations in serum compared to preoperative value |
Secondary
| Measure | Time frame |
|---|---|
| association of S-100B and NSE concentrations in serum with intraoperative cerebral near infrared spectroscopy values. | within 24 hours after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| association of S-100B and NSE concentrations in serum with cumulative doses of sedative agents | within 24 hours pre surgery to 3 days after surgery | Pre and postoperative S-100B and NSE concentrations in serum will be correlated with the administered pre and postoperative cumulative doses of sedatives and analgesics |
Countries
Lithuania
Outcome results
None listed