Individual Cerebral Hemodynamic Oxygenation Relationships
Cerebral Hemodynamics- ICHOR II
Matthew Borzage
30 participants
Jun 9, 2020
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
Inclusion Criteria7
- 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.
Exclusion Criteria8
- 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)
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Interventions
Patient's will be randomized to the group receiving propofol, or the group receiving sevoflurane.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04435834