Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4

Children's Hospital Los Angeles

Status and phase: Not yet enrolling; Phase 4

Conditions: Anesthesia; Reaction; Anesthesia

Treatments: Drug: Randomization of Propofol or Dexmedetomidine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07103616

CHLA-25-00084

5K25HL153954-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 130 estimated patients

Sex: All

Ages: Under 7 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Propofol

Experimental group

Description:

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.

Treatment:

Drug: Randomization of Propofol or Dexmedetomidine

Dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Randomization of Propofol or Dexmedetomidine