Influence of General Anesthesia on the Dynamic Changes in Brain Damage Markers During and After Craniosynostosis Operations in Infancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Blood biomarker level of neurofilament light chain (NfL)
Study Overview
Brief Summary
The issue of anesthetics neurotoxicity is one of the most discussed topics in pediatric anesthesiology, thus it opens the question of the safety of commonly used anesthetics in the pediatric patient. Preclinical studies have shown that anesthetics can have a toxic effect on the maturing brain of pups and cause cognitive impairment. In human medicine, the influence of anesthetics is studied by monitoring the psychomotor development of children who have undergone surgery under general anesthesia. Some work deals with laboratory evidence of brain damage due to general anesthesia, but none of the work deals with the observation of markers of brain damage in infants. The aim of this work is to examine the dynamics of changes in the concentrations of selected markers of brain damage in craniosynostosis operations under general anesthesia in infants in order to optimize perioperative management and the correct timing of surgery.
Detailed Description
More than twenty years ago, experimental work found that anesthetics can be toxic to the maturing brain of animal pups and cause cognitive impairment (Ikonomidou, 1999). The presented evidence suggested that the action of commonly used anesthetics triggers biochemical and morphological changes in immature neurons, which ultimately lead to their extinction (Creeley, 2013; Liu, 2012; Brambrink, 2010). Recent clinical studies have shown that general anesthesia can also have a negative effect on a child's cognitive functions (DiMaggio, 2017; Bong, 2013; Naumann, 2012; Flick, 2011). In another published study, it was found that the effect of general anesthesia in younger children leads to a more significant increase in markers of brain damage, neuron-specific enolase (NSE) and S100B protein (S100B), compared to older children (Stojanovic Stipic, 2017). It has also been shown, that the level of neurofilament light chain (NfL), a biomarker of axonal damage found in wide variety of neurological disorders (Khalil, 2018), is increased in adult patient's blood after anesthesia (Evered, 2018). Knowing the dynamics of brain damage markers can help optimize perioperative management and consideration of postponing the consider postponing surgery until later in childhood.
The aim of the submitted project is:
- To determine the dynamic changes in the concentration of selected markers of brain damage (NSE, S100B and NfL) during inhalation anesthesia in infants.
- To determine the dynamic changes in the concentration of these markers depending on:
A) age of the child B) duration of general anesthesia C) type of operation (open cranioplasty versus endoscopic cranioplasty) 3. Assessment of psychomotor development in the preoperative and postoperative period with an interval of 1 year after the operation and in the 36th month of the child's life. 4. Analysis of the relationship between changes in psychomotor development and changes in the concentration of brain damage markers. 5. Publication and implementation of the results into clinical practice.
Main benefit:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients indicated for surgical treatment of single-layer craniosynostosis will be selected for the study. Surgical treatment will be performed according to conventional indications (endoscopic correction in patients under 6 months of age, open correction in patients older than 6 months) under general anesthesia. ASA 1 -
- •The signing of informed consent to inclusion in the study is also a condition. In the preoperative period, the investigators will assess the achieved developmental level of the child using the Bayley scale (Bayley - III).
- •The child's parents will sign an informed consent to be included in the study.
Exclusion Criteria
- •Patients with comorbidities, syndromic craniosynostosis will be excluded from the study.
Outcomes
Primary Outcomes
Blood biomarker level of neurofilament light chain (NfL)
Time Frame: 48 hours
Three determinations of the level of NfL, Immediately after the introduction of general anesthesia; 2, immediately after the end of anesthesia; 3, 48 hours after anesthesia
Blood biomarker level of protein S100
Time Frame: 48 hours
Three determinations of the level of protein S100- 1, Immediately after the introduction of general anesthesia; 2, immediately after the end of anesthesia; 3, 48 hours after anesthesia
Blood biomarker level of neuron-specific enolase (NSE)
Time Frame: 48 hours
Three determinations of the level of NSE- 1, Immediately after the introduction of general anesthesia; 2, immediately after the end of anesthesia; 3, 48 hours after anesthesia
Secondary Outcomes
- child's psychomotor development (PMV)(36 months)