Individual Cerebral Hemodynamic Oxygenation Relationships - ICHOR 4
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in cerebral blood flow (ml blood/100g/min)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participant and care provider will be aware randomization status. Investigator and outcomes assessor will be masked.
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Propofol
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.
干预措施: Randomization of Propofol or Dexmedetomidine (Drug)
Dexmedetomidine
Subject will receive Dexmedetomidine during their MRI. Dosage form: injectable solution. Dosage: Generally, initiate at 0.6 mcg/kg/hour and titrate to achieve desired clinical effect with dosages ranging from 0.2 to 1 mcg/kg/hour or as per clinical standard of care appropriate for specific subjects.
Frequency and duration: continuous infusion while undergoing MRI.
干预措施: Randomization of Propofol or Dexmedetomidine (Drug)
结局指标
主要结局
Change in cerebral blood flow (ml blood/100g/min)
时间窗: 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.
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)
时间窗: 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
T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anesthesia on cerebral metabolic rate of oxygen.
次要结局
未报告次要终点
研究者
Matthew Borzage
Assistant Professor of Research Pediatrics
Children's Hospital Los Angeles