NEMARKO: Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: neonates and infants requiring surgery neonates and infants in whom blood samples for measurement of S-100 B protein in serum and NSE protein in serum are taken pre-operatively and 1-st, 2-nd and 3-rd post-operatively. During anesthesia cerebral near infrared spectroscopy is continuously applied until the wound closure. |
Procedure: Cerebral 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.
Other Names:
Other: S-100B protein in serum
0,5-1 ml of blood from periferal site for determination of serum S-100B concentration.
Other Names:
Other: NSE protein in serum
0,5-1 ml of blood from periferal site for determination of serum NSE concentration.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- association of S-100B and NSE concentrations in serum with intraoperative cerebral near infrared spectroscopy values. [within 24 hours after surgery]
Other Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients, undergoing general, thoracic, urological surgery for congenital anomalies or disease
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signed written informed consent by parents/official caregivers
Exclusion Criteria:
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cardiac surgery
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any evidence of neurological disease
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sepsis
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limited ability to obtain blood samples
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clinically significant anemia
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physical status of the patients corresponding to American Society of Anesthesiologists (ASA) class 4 and 5.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | Lithuania | 50009 |
Sponsors and Collaborators
- Lithuanian University of Health Sciences
- Research Council of Lithuania
Investigators
- Principal Investigator: Danguole C Rugyte, MD. PhD, Lithuanian University of Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
- Jensen E, Sandström K, Andréasson S, Nilsson K, Berggren H, Larsson LE. Increased levels of S-100 protein after cardiac surgery with cardiopulmonary bypass and general surgery in children. Paediatr Anaesth. 2000;10(3):297-302.
- Robertson DR, Justo RN, Burke CJ, Pohlner PG, Graham PL, Colditz PB. Perioperative predictors of developmental outcome following cardiac surgery in infancy. Cardiol Young. 2004 Aug;14(4):389-95.
- Tina LG, Frigiola A, Abella R, Tagliabue P, Ventura L, Paterlini G, Li Volti G, Pinzauti S, Florio P, Bellissima V, Minetti C, Gazzolo D. S100B protein and near infrared spectroscopy in preterm and term newborns. Front Biosci (Elite Ed). 2010 Jan 1;2(1):159-64.
- Vicente E, Tramontina F, Leite MC, Nardin P, Silva M, Karkow AR, Adolf R, Lucion AB, Netto CA, Gottfried C, Gonçalves CA. S100B levels in the cerebrospinal fluid of rats are sex and anaesthetic dependent. Clin Exp Pharmacol Physiol. 2007 Nov;34(11):1126-30.
- Wang S, Peretich K, Zhao Y, Liang G, Meng Q, Wei H. Anesthesia-induced neurodegeneration in fetal rat brains. Pediatr Res. 2009 Oct;66(4):435-40. doi: 10.1203/PDR.0b013e3181b3381b.
- BE-2-43