Individual Cerebral Hemodynamic Oxygenation Relationships
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorMatthew Borzage
About this trial
This is a randomized controlled trial in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by two types of anesthesia: propofol or sevoflurane. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of propofol and sevoflurane are in clinical equipoise will be offered to have the anesthesia they will receive during their MRI randomized. All eligible subjects will be asked to provide informed consent before participating in the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Propofol or Sevoflurane
DrugPatient's will be randomized to the group receiving propofol, or the group receiving sevoflurane.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: PropofolExperimental treatment 1 intervention
Group B: SevofluraneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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, through (2) MRI completion, an average of 60 minutes.2
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, through (2) MRI completion, an average of 60 minutes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Matthew Borzage
Lead sponsor
Children's Hospital Los Angeles
Sponsor institution
Source ClinicalTrials.gov