RecruitingPhase 4NCT04435834

Individual Cerebral Hemodynamic Oxygenation Relationships

Cerebral Hemodynamics- ICHOR II


Sponsor

Matthew Borzage

Enrollment

30 participants

Start Date

Jun 9, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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

Max Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This study is looking at how the brains of very young children (from birth to 1 year old) use oxygen during MRI scans that require anesthesia. When babies need an MRI for clinical reasons, they usually need to be sedated to stay still. Two common anesthetic drugs — propofol and sevoflurane — may affect blood flow and oxygen use in the brain differently. Since the infant brain is rapidly developing, understanding these differences matters for the safety of routine clinical care. The study collects brain imaging data and oxygen measurements during anesthesia for MRIs that the babies were already going to have for medical reasons. No extra procedures are added beyond a brief extension (up to 10 minutes) of the MRI. The goal is to build a detailed understanding of normal and abnormal brain oxygen dynamics in infants. You may be eligible if: - Your baby is between birth and 1 year of age - Your baby is scheduled for a clinically indicated MRI at the study institution - Your baby requires clinical anesthesia for their MRI - Your baby is medically stable enough to tolerate a brief extension of the MRI scan You may NOT be eligible if: - Your baby has an MRI-incompatible device or implant (e.g., pacemaker) - Your baby was born before 25 weeks of gestational age - Your baby is too medically unstable to extend the MRI - Your baby has known risk factors for propofol infusion syndrome or malignant hyperthermia - Your baby has a known neuromuscular disease like Duchenne muscular dystrophy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropofol or Sevoflurane

Patient's will be randomized to the group receiving propofol, or the group receiving sevoflurane.


Locations(1)

Children's Hospital Los Angeles

Los Angeles, California, United States

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NCT04435834


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