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NCT Number: NCT07103616

Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4

The goal of this clinical trial is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by two types of anesthesia: Propofol or Dexmedetomidine. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of Propofol and Dexmedetomidine are in clinical equipoise will be offered to have the anesthesia they will receive during their MRI randomized.

* Change in cerebral blood flow (ml blood/100g/min) * Change in cerebral metabolic rate of oxygen (ml O2/100g/min)

Researchers will compare Propofol (Group A) to Dexmedetomidine (Group B) to see if compare the hemodynamic response to anesthesia.

Participants will be randomized to receive one of two equally safe anesthetics (Propofol or Dexmedetomidine).

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Key information

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location contact

Hannah Wiseman

CONTACT

[email protected]

323-361-3963

Matthew Borzage, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

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 dexmedetomidine better for their clinical outcome.
  • Patients between birth and up-to 7 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)
  • 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)

Treatment and study plan

Randomization of Propofol or Dexmedetomidine

Drug

This intervention is a randomization of Propofol or Dexmedetomidine. Each group will receive three minutes of research images, followed by induction of anesthesia and immediately followed by three minutes of imaging. The subject will receive standard care clinical magnetic resonance imaging for 45 minutes and three minutes of research images at the end of the scan.

Primary outcomes

  1. 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, (2) after induction of anesthesia, (3) 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.

  2. 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, (2) after induction of anesthesia, (3) 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Wiseman

CONTACT

[email protected]

323-361-3963

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: ICHOR

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

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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