Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 7
SponsorChildren's Hospital Los Angeles

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Randomization of Propofol or Dexmedetomidine

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital Los Angeles

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator