Clinical trial NCT03022240: Neurobiological and Cognitive Changes Following Exposure to Either Sevoflurane- or Propofol-based Anesthesia in Children
Official title: Neurobiological, Cognitive-affective and Behavioral Changes Following Exposure to Either Sevoflurane- or Propofol-based Anesthesia in Children Undergoing MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cognitive Change
Behavior
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

Those between the ages 2 to 5 years who require general anesthesia for MRI Brain and have an American Society of Anesthesiologists' physical status of I to II

Exclusion Criteria:

* Emergency cases
* Intubated prior to MRI
* Allergies/contraindication to anesthetics
* Requirement of a painful procedure with MRI
* Significant developmental delay
* Autism or suspected autism
* History of extreme prematurity \<28 wks gestational age
* Sedation or general anesthesia in the last 14 days
* Receiving chemotherapy or radiation

Primary outcomes:
measure: Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV)
timeFrame: 12-15 weeks from date of randomization
Secondary outcomes:
measure: The Child Behavior Checklist (CBCL) 1.5 to 5 years
timeFrame: Change from baseline at 12-13 weeks after randomization
Other outcomes:
measure: The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
timeFrame: Change from baseline within 1 week after randomization
measure: The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
timeFrame: Change from baseline within 2-3 weeks after randomization
measure: The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
timeFrame: Change from baseline within 12-13 weeks after randomization
measure: The Post Hospital Behavior Questionnaire (PHBQ)
timeFrame: Within 1 week after randomization
measure: The Post Hospital Behavior Questionnaire (PHBQ)
timeFrame: Within 2-3 weeks after randomization
measure: The Modified Yale Preoperative Anxiety Scale (mYPAS)
timeFrame: On the day of randomization, obtained just prior to the intervention
measure: Pediatric Anesthesia Emergence Delirium (PAED) Scale
timeFrame: On the day or randomization, obtained immediately after the intervention
measure: Nuclear Magnetic Resonance Spectroscopy (NMRS)
timeFrame: On the day of randomization, obtained during the intervention
measure: Resting State Functional Magnetic Resonance Imaging (rfMRI)
timeFrame: On the day of randomization, obtained during the intervention
measure: Inflammatory Markers
timeFrame: On the day of randomization, change from baseline, obtained immediately after the intervention
measure: Blood metabolites
timeFrame: On the day of randomization, change from baseline, obtained immediately after the intervention
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Tiffany Rice, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: