Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4

NCT ID: NCT07103616

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-09-01

Brief Summary

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).

Conditions

Anesthesia; Reaction; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Randomization of Propofol or Dexmedetomidine

Intervention Type: 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.

Dexmedetomidine

Subject will receive Dexmedetomidine during their MRI. Dosage form: injectable solution. Dosage: Generally, initiate at 0.6 mcg/kg/hour and titrate to achieve desired clinical effect with dosages ranging from 0.2 to 1 mcg/kg/hour or as per clinical standard of care appropriate for specific subjects.

Frequency and duration: continuous infusion while undergoing MRI.

Group Type: EXPERIMENTAL

Randomization of Propofol or Dexmedetomidine

Intervention Type: 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.

Interventions

Randomization of Propofol or Dexmedetomidine

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.

Intervention Type: DRUG

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 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)

• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Matthew Borzage

Assistant Professor of Research Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Borzage, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

Central Contacts

Hannah Wiseman

Role: CONTACT

hwiseman@chla.usc.edu

323-361-3963

Facility Contacts

Hannah Wiseman

Role: primary

hwiseman@chla.usc.edu

323-361-3963

Other Identifiers

5K25HL153954-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHLA-25-00084

Identifier Type: -

Identifier Source: org_study_id