Recruiting

Observational Study

Sponsor:

Matthew Borzage

Code:

NCT04435834

Conditions

Anesthesia

Anesthesia; Reaction

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Propofol or Sevoflurane

Study Details

Brief summary:

This is a randomized controlled trial in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by two types of anesthesia: propofol or sevoflurane. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of propofol and sevoflurane are in clinical equipoise will be offered to have the anesthesia they will receive during their MRI randomized. All eligible subjects will be asked to provide informed consent before participating in the study.

Conditions

Anesthesia

Anesthesia; Reaction

Study ID

NCT04435834

Start date

Jun 9, 2020

Status verified date

Aug, 2024

Completion date

Sep 10, 2026

Anticipated

Primary completion date

Sep 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients who are scheduled for a clinically indicated MRI at the sponsor institution.
  • Patients who are able to tolerate an MRI.
  • Patients who require clinical anesthesia for their MRI.
  • Patients with conditions not believed to alter oxygen metabolism or blood flow in the brain, including but not limited to patients with orthopedic indications, undescended testicles, hernia repairs, term equivalent age scans.
  • Patients who have no medical conditions that make the use of propofol or sevoflurane better for their clinical outcome.
  • Patients between birth and up-to 1 year of age.
  • Patients with conditions known to alter oxygen metabolism or blood flow in the brain, e.g. traumatic brain injury, hypoxic ischemic encephalopathy, tumor.

Exclusion Criteria:

  • Patients with an MRI-incompatible device or implant (e.g. pacemakers, stents)
  • Preterm infants less than 25 weeks postmenstrual age (PMA) at the time of the scan.
  • Patients who are clinically too unstable to extend their MRI by up-to 10 minutes.
  • Patients who do not require clinical anesthesia.
  • Patients at risk for propofol infusion syndrome (known severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG ST segment elevation, and/or cardiac failure)
  • Patients at risk for sevoflurane-based malignant hyperthermia (known ryanodine receptor mutations)
  • Patient at risk for sensitivity to volatile halogenated anesthetic agents (known congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval),
  • Patients with Perioperative Hyperkalemia (known neuromuscular disease, particularly Duchenne muscular dystrophy)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Propofol

Subject will receive propofol anesthesia during their MRI. Dosage form: injectable solution. Dosage: 100-300 mcg/kg/min, or as per clinical standard of care appropriate for specific subjects.

Frequency and duration: continuous infusion while undergoing MRI.

experimental: Sevoflurane

Subject will receive sevoflurane anesthesia during their MRI. Dosage form: volatile liquid for inhalation Dosing: 0-1 month full term neonate (3.3% in oxygen), 1-6 months old (3% in oxygen), 6 months to <3 years old (2.8% in oxygen), or as per clinical standard of care appropriate for specific subjects.

Frequency and duration: continuous infusion while undergoing MRI.

Interventions

Propofol or Sevoflurane

Patient's will be randomized to the group receiving propofol, or the group receiving sevoflurane.

Primary outcome measure

  • Change in cerebral blood flow (ml blood/100g/min) [ Time Frame: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes. ]
  • Change in cerebral metabolic rate of oxygen (ml O2/100g/min) [ Time Frame: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes. ]

Central Contacts and Locations

Central contacts

Hannah Wiseman

323-361-3963hwiseman@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

More Information

Sponsor

Matthew Borzage

Last update posted

Sep 3, 2024

Last verified

Aug, 2024

Keywords

  • Magnetic Resonance Imaging
  • Cerebral Blood Flow
  • Cerebral Metabolism
  • Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Matthew Borzage on 2024-09-03.