Behavior, Cognitive Change
Conditions
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.
Interventions
DRUGPropofol
The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol)
DRUGSevoflurane
The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol)
DRUGAmetop
Each patient will receive Ametop local anesthetic to the dorsum of both hands 30-45 minutes prior to induction.
DRUGOndansetron
Each patient will receive the antiemetic ondansetron 0.1mg/kg IV.
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) | 12-15 weeks from date of randomization | The WPPSI - IV is designed for children aged 2.5 to 7.5 years, and is used to assess general intelligence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Child Behavior Checklist (CBCL) 1.5 to 5 years | Change from baseline at 12-13 weeks after randomization | The CBCL is widely used for identifying problem behaviors in children ages 1.5 to 5 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Modified Yale Preoperative Anxiety Scale (mYPAS) | On the day of randomization, obtained just prior to the intervention | The mYPAS is the current gold standard for assessing anxiety during induction of anesthesia for children ages 2-16 years. |
| Pediatric Anesthesia Emergence Delirium (PAED) Scale | On the day or randomization, obtained immediately after the intervention | Validated tool to measure emergence delirium in children. |
| Nuclear Magnetic Resonance Spectroscopy (NMRS) | On the day of randomization, obtained during the intervention | Glucose, lactate, choline and NAA values will be obtained from the parietal cortex |
| The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) | Change from baseline within 1 week after randomization | The BRIEF-P is the first standardized rating scale designed to specifically measure executive function in preschool-aged children (ages 2-5). |
| Inflammatory Markers | On the day of randomization, change from baseline, obtained immediately after the intervention | Concentrations of plasma IL-1b, TNF-a, IL-6, IL-10 will be quantified |
| Blood metabolites | On the day of randomization, change from baseline, obtained immediately after the intervention | Concentrations of plasma proteins, peptides and metabolites will be quantified |
| Resting State Functional Magnetic Resonance Imaging (rfMRI) | On the day of randomization, obtained during the intervention | Resting functional brain networks will be identified and compared between groups |
| The Post Hospital Behavior Questionnaire (PHBQ) | Within 1 week after randomization | The PHBQ asks parents to rate their child's behavior on 27 items concerning sleep, eating, internalizing and externalizing behaviors. For each item parents must compare their child's current behavior with their behavior one week prior to hospitalization. |
Countries
Canada
Outcome results
None listed