Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4

Обзор

The goal of this clinical trial is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by two types of anesthesia: Propofol or Dexmedetomidine. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of Propofol and Dexmedetomidine are in clinical equipoise will be offered to have the anesthesia they will receive during their MRI randomized. * Change in cerebral blood flow (ml blood/100g/min) * Change in cerebral metabolic rate of oxygen (ml O2/100g/min) Researchers will compare Propofol (Group A) to Dexmedetomidine (Group B) to see if compare the hemodynamic response to anesthesia. Participants will be randomized to receive one of two equally safe anesthetics (Propofol or Dexmedetomidine).

Вмешательства

• Препарат Randomization of Propofol or Dexmedetomidine
  This intervention is a randomization of Propofol or Dexmedetomidine. Each group will receive three minutes of research images, followed by induction of anesthesia and immediately followed by three minutes of imaging. The subject will receive standard care clinical magnetic resonance imaging for 45 minutes and three minutes of research images at the end of the scan.

Первичные конечные точки

• Change in cerebral blood flow (ml blood/100g/min) [Срок оценки: Time points over which the change is assessed: change from (1) start of MRI, (2) after induction of anesthesia, (3) MRI completion, an average of 60 minutes.]
• Change in cerebral metabolic rate of oxygen (ml O2/100g/min) [Срок оценки: Time points over which the change is assessed: change from (1) start of MRI, (2) after induction of anesthesia, (3) MRI completion, an average of 60 minutes]

Критерии участия

Критерии включения

• 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 dexmedetomidine better for their clinical outcome.
• Patients between birth and up-to 7 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.

Критерии исключения

• 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)
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT07103616 · CHLA-25-00084 · 5K25HL153954-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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