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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhalational Technique | Experimental | All patients will receive Ametop local anesthetic to the dorsum of both hands 30-45 minutes prior to induction. After inhalation induction of anesthesia with sevoflurane (in 100% O2), an IV will be obtained. Anesthesia will be maintained with sevoflurane (in a mixture of air:oxygen) with a minimum alveolar concentration of 1.0-1.3, titrated to effect. No long acting opioids or nitrous oxide will be used. Airway management will be at the discretion of the anesthesiologist. Each patient will receive the antiemetic ondansetron 0.1mg/kg IV. |
|
| Total Intravenous Anesthetic Technique | Experimental | All patients will receive Ametop local anesthetic to the dorsum of both hands 30-45 minutes prior to IV insertion. Once an IV is established, patients will receive an IV bolus of propofol (2-6mg/kg). Anesthesia will be maintained with a propofol infusion starting at 250 mcg/kg/min and titrated to effect. Airway management will be at the discretion of the anesthesiologist. Each patient will receive the antiemetic ondansetron 0.1mg/kg IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol) |
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) | The WPPSI - IV is designed for children aged 2.5 to 7.5 years, and is used to assess general intelligence. | 12-15 weeks from date of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The Child Behavior Checklist (CBCL) 1.5 to 5 years | The CBCL is widely used for identifying problem behaviors in children ages 1.5 to 5 years | Change from baseline at 12-13 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) | The BRIEF-P is the first standardized rating scale designed to specifically measure executive function in preschool-aged children (ages 2-5). | Change from baseline within 1 week after randomization |
| The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Rice, PhD, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| D013748 | Tetracaine |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Sevoflurane | Drug | The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol) |
|
| Ametop | Drug | Each patient will receive Ametop local anesthetic to the dorsum of both hands 30-45 minutes prior to induction. |
|
| Ondansetron | Drug | Each patient will receive the antiemetic ondansetron 0.1mg/kg IV. |
|
The BRIEF-P is the first standardized rating scale designed to specifically measure executive function in preschool-aged children (ages 2-5). |
| Change from baseline within 2-3 weeks after randomization |
| The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) | The BRIEF-P is the first standardized rating scale designed to specifically measure executive function in preschool-aged children (ages 2-5). | Change from baseline within 12-13 weeks after randomization |
| The Post Hospital Behavior Questionnaire (PHBQ) | 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. | Within 1 week after randomization |
| The Post Hospital Behavior Questionnaire (PHBQ) | 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. | Within 2-3 weeks after randomization |
| The Modified Yale Preoperative Anxiety Scale (mYPAS) | The mYPAS is the current "gold standard" for assessing anxiety during induction of anesthesia for children ages 2-16 years. | On the day of randomization, obtained just prior to the intervention |
| Pediatric Anesthesia Emergence Delirium (PAED) Scale | Validated tool to measure emergence delirium in children. | On the day or randomization, obtained immediately after the intervention |
| Nuclear Magnetic Resonance Spectroscopy (NMRS) | Glucose, lactate, choline and NAA values will be obtained from the parietal cortex | On the day of randomization, obtained during the intervention |
| Resting State Functional Magnetic Resonance Imaging (rfMRI) | Resting functional brain networks will be identified and compared between groups | On the day of randomization, obtained during the intervention |
| Inflammatory Markers | Concentrations of plasma IL-1b, TNF-a, IL-6, IL-10 will be quantified | On the day of randomization, change from baseline, obtained immediately after the intervention |
| Blood metabolites | Concentrations of plasma proteins, peptides and metabolites will be quantified | On the day of randomization, change from baseline, obtained immediately after the intervention |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |