Individual Cerebral Hemodynamic Oxygenation Relationships

NCT04435834 | Recruiting Phase 4 FDA Drug

• 1 other identifier: CHLA-20-00136
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Anesthesia; Reaction

Keywords

Magnetic Resonance Imaging; Cerebral Blood Flow; Cerebral Metabolism; Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 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.

  Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.

Study Arms (2)

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.

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.

Drug: Propofol or Sevoflurane

Interventions

Propofol or Sevoflurane DRUG

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

Propofol; Sevoflurane

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Matthew Borzage: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Matthew Borzage, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Wiseman

CONTACT

323-361-3963; hwiseman@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant and care provider will be aware randomization status. Investigator and outcomes assessor will be masked.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 17, 2020
• Study Start: June 9, 2020
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)