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Anesthesia and Brain Blood Flow Study for Infants

This study is looking at how two common types of anesthesia, propofol and sevoflurane, affect blood flow and oxygen use in the brains of infants. We want to see if there are differences between these two anesthetics when given to babies who need anesthesia for an MRI scan. You might be able to join if your child is under one year old, needs an MRI, and requires anesthesia. The study will measure changes in brain blood flow and oxygen use during the MRI, which typically lasts about 60 minutes. The study aims to enroll 30 participants, but the current recruitment status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to receive either propofol or sevoflurane. The study plans to enroll 30 participants.
What's involved
If your child participates, they will receive either propofol or sevoflurane during their MRI. Additional images will be taken during the MRI, which will add up to 10 extra minutes under anesthesia and in the scanner.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for brain blood flow and oxygen use are taken during the MRI, which is an average of 60 minutes.

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NCT04435834

Individual Cerebral Hemodynamic Oxygenation Relationships

Recruiting
PHASE4Up to 1InterventionalBasic science
Matthew Borzage
~30 participants
Updated 2024-09-03 on ClinicalTrials.gov
What's tested:Propofol or Sevoflurane

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in cerebral blood flow (ml blood/100g/min)
Measured over Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.
+1 more outcome measured

Conditions

Anesthesia
Anesthesia; Reaction

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Anesthesia Procedure

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Matthew Borzage, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles

Who to contact

Hannah Wiseman
[email protected]
323-361-3963
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

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

    Phase contrast (PC) acquisition via MRI will be used to assess any impact of anesthesia on cerebral blood flow.

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

    T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anesthesia on cerebral metabolic rate of oxygen.