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Influence of General Anesthesia on the Dynamic Changes in Brain Damage Markers During and After Craniosynostosis Operations in Infancy

Study acronym: TAnBrainDam
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record status
This record was last updated June 23, 2023 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study description expanded, about 12 words
    • Eligibility criteria expanded, about 1 word
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05911139
Lead Sponsor Comenius University
Conditions
(from sponsor)		 Craniosynostosis, Anesthesia
Related terms Charcot-Marie-Tooth disease, Type 1F, Craniosynostoses, Neurotoxicity Syndromes
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov