Individual Cerebral Hemodynamic Oxygenation Relationships

Part of paid clinical trials in Los Angeles, California.

Sponsor
Matthew Borzage
Study ID
NCT04435834
Phase
PHASE4
Status
Recruiting
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Conditions

  • Anesthesia
  • Anesthesia; Reaction

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • Propofol or Sevoflurane — DRUG
    Patient's will be randomized to the group receiving propofol, or the group receiving sevoflurane.

Study Details

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.

Key Dates

Start date
Jun 9, 2020
Status verified
Aug 2024
Primary completion
Sep 10, 2026
Completion
Sep 10, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Propofol
    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.
  • Experimental: Sevoflurane
    Subject will receive sevoflurane anesthesia during their MRI. Dosage form: volatile liquid for inhalation Dosing: 0-1 month full term neonate (3.3% in oxygen), 1-6 months old (3% in oxygen), 6 months to \<3 years old (2.8% in oxygen), or as per clinical standard of care appropriate for specific subjects. Frequency and duration: continuous infusion while undergoing MRI.

Primary Outcome Measure

Change in cerebral blood flow (ml blood/100g/min) [ 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Hannah Wiseman Wiseman

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By research site
Children's Hospital Los Angeles· Los Angeles, CA

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