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临床试验/NCT06041659
NCT06041659招募中不适用

Functional Magnetic Resonance-Based Observations of Brain Networks and Cerebrovascular Reactivity in Patients With Moyamoya Disease Under Anesthetic Sedation, A Prospective Observational Cohort Study

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
Changes of brain functional network

研究概览

简要总结

Moyamoya disease is characterized by progressive stenosis of the genesis of the distal internal carotid arteries bilaterally and progressive generation of compensatory pathological vascular networks at the basis cranii, and these pathological vasculature has poor vascular reactivity. Perioperative circulatory management of patients with smoky vessels to ensure perfusion of brain tissue and integrity of brain network during surgery to minimize postoperative impairment of neurological functions, including motor, sensory, emotional and cognitive functions, is the key point of perioperative circulatory management of moyamoya disease. Functional Magnetic Resonance Imaging (fMRI) has been routinely used in various cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network connectivity. The purpose of this study is to observe the changes in cerebral blood flow, cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas under anesthesia to provide a basis for exploring anesthesia management to improve cognitive function and cerebral network connectivity in these patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with moyamoya disease scheduled for direct or indirect intracranial and extracranial revascularization surgery
  • Age between 18-65 years
  • Obtain written informed consent.

排除标准

  • Patients with preoperative claustrophobia, sensory or motor aphasia that are unable to understand and cooperate with the examination
  • Preoperative cranial imaging suggesting cerebral infarction lesion diameter >15mm
  • Patients allergic to anesthetic drugs
  • Metal implants in the body
  • Undergoing other experimental drug or instrumentation trials

结局指标

主要结局

Changes of brain functional network

时间窗: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min

次要结局

  • Postoperative delirium(Day1-5 after surgery)
  • Electroencephalogram changes(Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuming Peng

Clinical Professor

Beijing Tiantan Hospital

研究点 (1)

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