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

NCT ID: NCT03022240

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-09-30

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.

Conditions

Cognitive Change; Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Inhalational Technique

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.

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: 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

Intervention Type: DRUG

Each patient will receive Ametop local anesthetic to the dorsum of both hands 30-45 minutes prior to induction.

Ondansetron

Intervention Type: DRUG

Each patient will receive the antiemetic ondansetron 0.1mg/kg IV.

Total Intravenous Anesthetic Technique

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.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: 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

Intervention Type: DRUG

Each patient will receive Ametop local anesthetic to the dorsum of both hands 30-45 minutes prior to induction.

Ondansetron

Intervention Type: DRUG

Each patient will receive the antiemetic ondansetron 0.1mg/kg IV.

Interventions

Propofol

The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol)

Intervention Type: DRUG

Sevoflurane

The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol)

Intervention Type: DRUG

Ametop

Each patient will receive Ametop local anesthetic to the dorsum of both hands 30-45 minutes prior to induction.

Intervention Type: DRUG

Ondansetron

Each patient will receive the antiemetic ondansetron 0.1mg/kg IV.

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiffany Rice, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB16-0104

Identifier Type: -

Identifier Source: org_study_id