Status:
RECRUITING
Individual Cerebral Hemodynamic Oxygenation Relationships
Lead Sponsor:
Matthew Borzage
Conditions:
Anesthesia
Anesthesia; Reaction
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04435834
Start Date
June 9 2020
End Date
September 10 2026
Last Update
September 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027