Comparing effects of two anesthesia types on brain blood flow and oxygen levels

Cerebral Hemodynamics- ICHOR II

This study is testing whether two types of anesthesia, propofol and sevoflurane, affect blood flow and oxygen levels in the brain differently during an MRI for patients.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: N/A to 1 Year
• Sex: All
• Sponsor: Children's Hospital Los Angeles (other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT04435834 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to investigate the differences in cerebral blood flow and oxygen metabolism between two types of anesthesia, propofol and sevoflurane, in patients undergoing clinical MRI. Eligible participants will be randomized to receive one of the two anesthetics during their MRI, with additional imaging conducted to measure cerebral blood flow and venous oxygenation. The study will ensure that both anesthetics are in clinical equipoise and will adhere to standard anesthesia safety protocols. Informed consent will be obtained from all participants prior to enrollment.

Who should consider this trial

Good fit: Ideal candidates include patients scheduled for a clinically indicated MRI who require anesthesia and are between birth and 1 year of age.

Not a fit: Patients with medical conditions that significantly alter oxygen metabolism or blood flow in the brain, or those with MRI-incompatible devices, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimizing anesthesia choices for better cerebral oxygenation and blood flow during MRI procedures.

How similar studies have performed: While studies comparing different anesthetics exist, this specific approach focusing on cerebral hemodynamics during MRI is relatively novel.

Eligibility criteria

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)

Where this trial is running

Los Angeles, California

• Children's Hospital Los Angeles — Los Angeles, California, United States (RECRUITING)

Study contacts

• Principal investigator: Matthew Borzage, PhD — Children's Hospital Los Angeles
• Study coordinator: Hannah Wiseman

Conditions: Anesthesia, Reaction, Magnetic Resonance Imaging, Cerebral Blood Flow, Cerebral Metabolism