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Completed

NCT Number: NCT03022240

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

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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Key information

Conditions

Cognitive Change Behavior

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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.

Primary outcomes

  1. Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV)

    Time frame: 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 outcomes

  1. The Child Behavior Checklist (CBCL) 1.5 to 5 years

    Time frame: 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 outcomes

  1. The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)

    Time frame: 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).

  2. The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)

    Time frame: Change from baseline within 2-3 weeks after randomization

    The BRIEF-P is the first standardized rating scale designed to specifically measure executive function in preschool-aged children (ages 2-5).

  3. The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)

    Time frame: Change from baseline within 12-13 weeks after randomization

    The BRIEF-P is the first standardized rating scale designed to specifically measure executive function in preschool-aged children (ages 2-5).

  4. The Post Hospital Behavior Questionnaire (PHBQ)

    Time frame: 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.

  5. The Post Hospital Behavior Questionnaire (PHBQ)

    Time frame: Within 2-3 weeks 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.

  6. The Modified Yale Preoperative Anxiety Scale (mYPAS)

    Time frame: 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.

  7. Pediatric Anesthesia Emergence Delirium (PAED) Scale

    Time frame: On the day or randomization, obtained immediately after the intervention

    Validated tool to measure emergence delirium in children.

  8. Nuclear Magnetic Resonance Spectroscopy (NMRS)

    Time frame: On the day of randomization, obtained during the intervention

    Glucose, lactate, choline and NAA values will be obtained from the parietal cortex

  9. Resting State Functional Magnetic Resonance Imaging (rfMRI)

    Time frame: On the day of randomization, obtained during the intervention

    Resting functional brain networks will be identified and compared between groups

  10. Inflammatory Markers

    Time frame: 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

  11. Blood metabolites

    Time frame: On the day of randomization, change from baseline, obtained immediately after the intervention

    Concentrations of plasma proteins, peptides and metabolites will be quantified

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Neurobiological, Cognitive-affective and Behavioral Changes Following Exposure to Either Sevoflurane- or Propofol-based Anesthesia in Children Undergoing MRI

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2017
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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