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| ID | Type | Description | Link |
|---|---|---|---|
| 5K25HL153954-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Wiseman | Contact | 323-361-3963 | hwiseman@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Borzage, PhD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Participant and care provider will be aware randomization status. Investigator and outcomes assessor will be masked.
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