Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and/or prolonged exposures are harmless and whether their effects are more pronounced in newborns and infants with brains more vulnerable to injury. One such specific group of patients is children with congenital heart disease (CHD). Nearly, half of the school-age survivors with CHD exhibit neurodevelopmental symptoms. It is thus important to elucidate whether any plausible neurotoxicity of the commonly used anesthetic agents can be observed in this population, and whether specific neuroprotective strategies can be demonstrated within the frame of a randomized controlled trial (RCT). Animal data have shown that dexmedetomidine (DEX) induces neuroprotective effects only at well-adjusted doses. One major issue with trials of anesthetic neurotoxicity is the latency between the conduct of these studies and the assessment of neurodevelopmental outcome. In contrast, the use of biomarkers of neuronal injury could be extremely valuable. Serum Neurofilament Light (NfL) has been shown to be a sensitive and specific marker of neuronal injury and is associated with neurologic outcome of children with various pathologies. The investigators hypothesize that in congenital heart surgery, use of DEX as main anesthetic agent in conjunction with low dose sevoflurane results in less release of serum NfL and is thus potentially less neurotoxic compared to the current standard of care. The hypothesis is tested with a RCT including patients between 0 - 3y undergoing surgery with cardiopulmonary bypass. To avoid any neurotoxicity due to anesthetic overdose, intraoperative burst suppression will be avoided. In addition to postoperative comparison of serum NfL, postoperative electroencephalogram and neurodevelopmental outcome of both groups will be compared taking into consideration the genetic background.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Participants will receive a dexmedetomidine infusion in addition to low dose sevoflurane anesthesia.
Participants will receive general anesthesia based on institutional's practice with commonly used doses of sevoflurane.
Concentration of serum Neurofilament Light
To show a difference of change in serum NfL concentrations between both groups at 24h compared to baseline values.
Time frame: At 24 hours postoperatively
Concentration of serum Neurofilament Light
Time frame: Baseline before start of anesthesia
Concentration of serum Neurofilament Light
Time frame: Start of cardiopulmonary bypass
Concentration of serum Neurofilament Light
Time frame: At 72 hours postoperatively
Concentration of serum Neurofilament Light
Time frame: At postoperative day 5
Neurodevelopmental outcome testing
Bailey Scales of Infant and Toddler Development - Third Edition. Higher scores are better.
Time frame: 3 months postoperatively
Neurodevelopmental outcome testing
Bailey Scales of Infant and Toddler Development - Third Edition. Higher scores are better.
Time frame: 6 months postoperatively
Postoperative electroencephalogram registration
Number of seizures
Time frame: 24 hours
Dose of Analgesics
Use and dose of analgesics
Time frame: 72 hours postoperatively
Renal function
Defined by pediatric RIFLE criteria
Time frame: 7 days postoperatively
Concentration of regional cerebral oxygenation
Area Under Curve of time spent below rSO2 levels of 50%; Area Under Curve of time spent below baseline rSO2 levels
Time frame: Intraoperatively
Postoperative electroencephalogram registration
Number of burst-suppression episodes
Time frame: 24 hours
Postoperative electroencephalogram registration
Duration of burst-suppression episodes
Time frame: 24 hours
Postoperative electroencephalogram registration
Duration of seizures
Time frame: 24 hours
Time of exsudation
time to extubation
Time frame: 7 days postoperatively
Pediatric Intensive Care Unit stay
Duration of stay in Pediatric Intensive Care Unit
Time frame: Up to 24 weeks
Hospital stay
Days of hospital stay
Time frame: Up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.