Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4

ConditionsAnesthesia; Reaction Anesthesia

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

130 Participants

are divided into 2 treatment groups

Group A: PropofolExperimental treatment 1 intervention

Group B: DexmedetomidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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 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.

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 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Los Angeles

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: