drugset / Trial / NCT03022240

Neurobiological and Cognitive Changes Following Exposure to Either Sevoflurane- or Propofol-based Anesthesia in Children

NCT03022240

Phase 3 Completed 50 enrolled University of Calgary
RandomizedParallel-groupOpen-labelSupportive care

Summary

The demand for magnetic resonance imaging (MRI) in pediatric patients is increasing due to its use in medical diagnosis and surveillance. Pediatric patients often require general anesthesia (GA) for MRI due to the need for prolonged immobility during the scanning process to obtain high quality images. Two widely used anesthetic techniques for pediatric MRIs are volatile-based anesthesia using sevoflurane and total intravenous anesthesia (TIVA) using propofol. Concerns have been raised regarding the potential neurotoxic effects of anesthetics on the developing brain. Within the animal literature, there is emerging evidence to suggest that both sevoflurane and propofol may cause inflammation, impacting brain cell survival and connections, thereby contributing to possible cognitive dysfunction. However, given the challenges in extrapolating the animal data to humans, and the relatively limited human cohort studies examining the long-term effects of anesthesia exposure, there is inadequate information available to make informed clinical decisions regarding the choice of optimal anesthetic agents for MRI in children. Therefore, this study will uniquely examine the mechanisms of two widely used anesthetics and their short and long-term impact on developmental outcomes in healthy children.

Timeline

Start
2017-01
Primary completion
2019-09
Completion
2019-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 250 ug/kg Intravenous
Subject Sevoflurane Other / unclassified 1 unknown Inhaled
Subject Sevoflurane Other / unclassified 1.3 unknown Inhaled
Background Ametop Unknown Topical
Background Ondansetron Other / unclassified 0.1 mg/kg Intravenous

Indications

No indication recorded.