Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Children's Hospital Los Angeles
- Study ID
- NCT07103616
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Anesthesia
- Anesthesia; Reaction
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 7 Years
- Healthy Volunteers
- Accepted
Interventions
- Randomization of Propofol or Dexmedetomidine — DRUGThis 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.
Study Details
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).
Key Dates
- Start date
- Sep 1, 2025
- Status verified
- Jul 2025
- Primary completion
- Sep 1, 2028
- Completion
- Sep 1, 2028
Study Design
- Enrollment
- 130 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: PropofolSubject 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: DexmedetomidineSubject 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.
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, (2) after induction of anesthesia, (3) MRI completion, an average of 60 minutes. ]
Central Contacts
- Hannah Wiseman323-361-3963
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Matthew Borzage, PhD (PRINCIPAL_INVESTIGATOR) |
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