Cerebral Hemodynamics- ICHOR II
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in cerebral metabolic rate of oxygen (ml O2/100g/min)
研究概览
简要总结
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.
详细描述
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.
Treatment:
All patients will be screened to ensure propofol and sevoflurane are in clinical equipoise. Those who meet eligibility criteria, and who undergo the informed consent, will be randomize to receive propofol or sevoflurane during their MRI. Standard-of-care anesthesia safety, dose and monitoring will not be changed. During their MRI, additional images will be acquired that measure the cerebral blood flow and cerebral venous oxygenation. These additional images will take up-to 10 extra minutes to acquire. This will increase the duration each subject spends under anesthesia, and in the MRI scanner by up-to a total of 10 extra minutes.
Safety Assessment:
To ensure that either propofol or sevoflurane are in clinical equipoise, all patients will be screened by an anesthesiologist. The experiment will occur in the standard-of-care clinical MRI environment. All patient safety and monitoring will remain in place. Throughout the induction, maintenance and recovery from anesthesia, all procedures will occur in the standard of care environment and will be overseen by trained clinical personnel.
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 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 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.
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)
- •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)
结局指标
主要结局
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, through (2) 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.
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, through (2) 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.
次要结局
未报告次要终点
研究者
Matthew Borzage
Principal Investigator
Children's Hospital Los Angeles