Anesthesia; ReactionPhase 4ICHORNCT07103616
Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4
A Phase 4 study testing Randomization of Propofol or Dexmedetomidine in people with Anesthesia; Reaction and Anesthesia, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Reaction, Anesthesia
- What is being tested?
- Randomization of Propofol or Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
Hannah Wiseman, 323-361-3963, hwiseman@chla.usc.edu
Matthew Borzage, PhD
About this study
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)
Read more
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
- Being tested
- Randomization of Propofol or Dexmedetomidine
- Keywords
- Magnetic Resonance Imaging, Cerebral Blood Flow, Cerebral Metabolism, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomization of Propofol or DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | 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. Receives: Drug: Randomization of Propofol or Dexmedetomidine |
| Dexmedetomidine | Experimental | 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. Receives: Drug: Randomization of Propofol or Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral blood flow (ml blood/100g/min)
Phase contrast (PC) acquisition via MRI will be used to assess any impact of anesthesia on cerebral blood flow.
Measured: 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.
Change in cerebral metabolic rate of oxygen (ml O2/100g/min)
T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anesthesia on cerebral metabolic rate of oxygen.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; ReactionStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Matthew Borzage, Children's Hospital Los Angeles
- Investigators
- Matthew Borzage, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103616
- Sponsor's protocol ID
- CHLA-25-00084
- Other IDs
- 5K25HL153954-03
- Acronym
- ICHOR
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4
- ClinicalTrials.gov ID
- NCT07103616
- Acronym / sponsor ID
- ICHOR / CHLA-25-00084
- Conditions
- Anesthesia; Reaction, Anesthesia
- Keywords
- Magnetic Resonance Imaging, Cerebral Blood Flow, Cerebral Metabolism, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Randomization of Propofol or DexmedetomidineSubject 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. |
| Dexmedetomidine | Experimental | Drug: Randomization of Propofol or 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. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomization of Propofol or DexmedetomidineThis 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. | Drug | Dexmedetomidine, Propofol |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Borzage, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Randomization of Propofol or Dexmedetomidine in people with Anesthesia; Reaction and Anesthesia, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Wiseman (323-361-3963, hwiseman@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.