AnesthesiaPhase 4ICHORNCT04435834
Individual Cerebral Hemodynamic Oxygenation Relationships
A Phase 4 study testing Propofol or Sevoflurane in people with Anesthesia and Anesthesia; Reaction, run by Matthew Borzage at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Anesthesia, Anesthesia; Reaction
- What is being tested?
- Propofol or Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2020to 10 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Patients who have no medical conditions that make the use of propofol or sevoflurane better for their clinical outcome.
- 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.
Who cannot join
- 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.
- Patients at risk for propofol infusion syndrome (known severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG ST segment elevation, and/or cardiac failure)
- Patients at risk for sevoflurane-based malignant hyperthermia (known ryanodine receptor mutations)
- Patient at risk for sensitivity to volatile halogenated anesthetic agents (known congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval),
- Patients with Perioperative Hyperkalemia (known neuromuscular disease, particularly Duchenne muscular dystrophy)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Hannah Wiseman Wiseman
About this study
Official title: Cerebral Hemodynamics- ICHOR II
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.
Read the detailed description
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.
Treatment:
All patients will be screened to ensure propofol and sevoflurane are in clinical equipoise. Those who meet eligibility criteria, and who undergo the informed consent, will be randomize to receive propofol or sevoflurane during their MRI. Standard-of-care anesthesia safety, dose and monitoring will not be changed. During their MRI, additional images will be acquired that measure the cerebral blood flow and cerebral venous oxygenation. These additional images will take up-to 10 extra minutes to acquire. This will increase the duration each subject spends under anesthesia, and in the MRI scanner by up-to a total of 10 extra minutes.
Safety Assessment:
To ensure that either propofol or sevoflurane are in clinical equipoise, all patients will be screened by an anesthesiologist. The experiment will occur in the standard-of-care clinical MRI environment. All patient safety and monitoring will remain in place. Throughout the induction, maintenance and recovery from anesthesia, all procedures will occur in the standard of care environment and will be overseen by trained clinical personnel.
Efficacy Assessment:
Cerebral blood flow and metabolism MRIs will be collected from all subjects.
- Conditions
- Anesthesia, Anesthesia; Reaction
- Being tested
- Propofol or Sevoflurane
- Keywords
- Magnetic Resonance Imaging, Cerebral Blood Flow, Cerebral Metabolism, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol or SevofluraneDrug
Patient's will be randomized to the group receiving propofol, or the group receiving sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | 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. Receives: Drug: Propofol or Sevoflurane |
| Sevoflurane | Experimental | 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. Receives: Drug: Propofol or Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time points over which the change is assessed: change from (1) start of MRI, through (2) 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.
Measured: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start9 Jun 2020
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in a stratified, blocked study design. Stratification is based on two factors: gestational age (2 groups: ≥37 weeks and ≤37 weeks) and postmenstrual age at MRI (2 groups: ≥37 weeks and ≤37 weeks). Blocking of each stratum is performed in groups of 4.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Borzage
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Borzage, Children's Hospital Los Angeles
- Investigators
- Matthew Borzage, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435834
- Sponsor's protocol ID
- CHLA-20-00136
- Acronym
- ICHOR
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2020
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Hemodynamics- ICHOR II
- ClinicalTrials.gov ID
- NCT04435834
- Acronym / sponsor ID
- ICHOR / CHLA-20-00136
- Conditions
- Anesthesia, Anesthesia; Reaction
- Keywords
- Magnetic Resonance Imaging, Cerebral Blood Flow, Cerebral Metabolism, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Matthew BorzageUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Treatment:
All patients will be screened to ensure propofol and sevoflurane are in clinical equipoise. Those who meet eligibility criteria, and who undergo the informed consent, will be randomize to receive propofol or sevoflurane during their MRI. Standard-of-care anesthesia safety, dose and monitoring will not be changed. During their MRI, additional images will be acquired that measure the cerebral blood flow and cerebral venous oxygenation. These additional images will take up-to 10 extra minutes to acquire. This will increase the duration each subject spends under anesthesia, and in the MRI scanner by up-to a total of 10 extra minutes.
Safety Assessment:
To ensure that either propofol or sevoflurane are in clinical equipoise, all patients will be screened by an anesthesiologist. The experiment will occur in the standard-of-care clinical MRI environment. All patient safety and monitoring will remain in place. Throughout the induction, maintenance and recovery from anesthesia, all procedures will occur in the standard of care environment and will be overseen by trained clinical personnel.
Efficacy Assessment:
Cerebral blood flow and metabolism MRIs will be collected from all subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a stratified, blocked study design. Stratification is based on two factors: gestational age (2 groups: ≥37 weeks and ≤37 weeks) and postmenstrual age at MRI (2 groups: ≥37 weeks and ≤37 weeks). Blocking of each stratum is performed in groups of 4.
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Propofol or SevofluraneSubject 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. |
| Sevoflurane | Experimental | Drug: Propofol or SevofluraneSubject 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. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
- Patients who have no medical conditions that make the use of propofol or sevoflurane better for their clinical outcome.
Key exclusion criteria (8 listed)
- 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.
- Patients at risk for propofol infusion syndrome (known severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG ST segment elevation, and/or cardiac failure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol or SevofluranePatient's will be randomized to the group receiving propofol, or the group receiving sevoflurane. | Drug | Propofol, Sevoflurane |
Primary outcome
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.
Phase contrast (PC) acquisition via MRI will be used to assess any impact of anesthesia on cerebral blood flow.
Change in cerebral metabolic rate of oxygen (ml O2/100g/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.
T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anesthesia on cerebral metabolic rate of oxygen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Borzage, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol or Sevoflurane in people with Anesthesia and Anesthesia; Reaction, run by Matthew Borzage at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Wiseman (323-361-3963, hwiseman@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.