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General Anesthetic

Propofol vs Sevoflurane for Anesthesia (ICHOR Trial)

Q: What potential dangers are associated with the use of Randomized sevoflurane?

There is an abundance of evidence suggesting Randomized sevoflurane's safety, so it earned a rating of 3.

Q: How many participants are being enrolled in this research program?

Affirmative. According to the clinicaltrials.gov database, this trial is actively recruiting participants and began on June 9th 2020. This study has been updated as recently as October 21st 2021 and requires 30 individuals at a single location.

Q: Are there still vacancies for participants in this research study?

Confirmed. According to the information located on clinicaltrials.gov, this medical study is currently enrolling patients. It first became available for public review June 9th 2020 and was last updated October 21st 2021 with a goal of recruiting 30 people from one location.

Phase 4

Recruiting

Led By Matthew Borzage, PhD

Research Sponsored by Matthew Borzage

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients between birth and up-to 1 year of age

Patients with conditions known to alter oxygen metabolism or blood flow in the brain, e.g. traumatic brain injury, hypoxic ischemic encephalopathy, tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time points over which the change is assessed: change from (1) start of mri, through (2) mri completion, an average of 60 minutes.

Awards & highlights

ICHOR Trial Summary

This trial is testing whether there are differences in brain function between two types of anesthesia. Subjects will be randomly assigned to receive either propofol or sevoflurane, and the effects on brain function will be measured.

Who is the study for?

This trial is for patients needing clinical anesthesia for an MRI, including those with conditions affecting brain oxygen or blood flow. It's open to infants up to 1 year old without medical issues that favor one anesthetic over another. Excluded are those with MRI-incompatible devices, certain genetic risks like Long QT Syndrome, and preterm infants under 25 weeks PMA.Check my eligibility

What is being tested?

The study compares the effects of two anesthetics—Propofol and Sevoflurane—on cerebral blood flow and oxygen metabolism during MRI procedures in a randomized controlled setup where participants are chosen by chance to receive one of the two drugs.See study design

What are the potential side effects?

Potential side effects may include changes in heart rate or rhythm, allergic reactions, breathing difficulties, fluctuations in blood pressure, dizziness upon waking up from anesthesia, nausea or vomiting.

ICHOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a patient under 1 year old.

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I have a condition that affects oxygen use or blood flow in my brain.

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I need anesthesia for my MRI scans.

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I can undergo an MRI scan.

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I have no health issues that require the use of propofol or sevoflurane.

ICHOR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time points over which the change is assessed: change from (1) start of mri, through (2) mri completion, an average of 60 minutes.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time points over which the change is assessed: change from (1) start of mri, through (2) mri completion, an average of 60 minutes.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time points over which the change is assessed: change from (1) start of mri, through (2) mri completion, an average of 60 minutes. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Change in cerebral metabolic rate of oxygen (ml O2/100g/min)

ICHOR Trial Design

2Treatment groups

Experimental Treatment

Group I: SevofluraneExperimental Treatment1 Intervention

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.

Group II: PropofolExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Matthew BorzageLead Sponsor

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,738 Total Patients Enrolled

Matthew Borzage, PhDPrincipal InvestigatorChildren's Hospital Los Angeles

Media Library

Propofol (General Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04435834 — Phase 4

Anesthesia Research Study Groups: Sevoflurane, Propofol

Anesthesia Clinical Trial 2023: Propofol Highlights & Side Effects. Trial Name: NCT04435834 — Phase 4

Propofol (General Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04435834 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential dangers are associated with the use of Randomized sevoflurane?

"There is an abundance of evidence suggesting Randomized sevoflurane's safety, so it earned a rating of 3."

Answered by AI

How many participants are being enrolled in this research program?

"Affirmative. According to the clinicaltrials.gov database, this trial is actively recruiting participants and began on June 9th 2020. This study has been updated as recently as October 21st 2021 and requires 30 individuals at a single location."

Answered by AI

Are there still vacancies for participants in this research study?

"Confirmed. According to the information located on clinicaltrials.gov, this medical study is currently enrolling patients. It first became available for public review June 9th 2020 and was last updated October 21st 2021 with a goal of recruiting 30 people from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Individual Cerebral Hemodynamic Oxygenation Relationships

Matthew Borzage 2020. "Individual Cerebral Hemodynamic Oxygenation Relationships". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04435834.