Study on the Neurovascular Coupling Function in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Thirty of participants with Cognitive function assessment based on "Direction of Chinese Binet Tests (third edition)"
研究概览
简要总结
Existing researches show that brain is an organ highly dependent on continuous blood supply. Energy and oxygen required for normal physiological activities in the brain are stably maintained by a neurovascular regulatory mechanism, also known as functional congestion. While under pathological condition such as ischemia, this regulatory mechanism would be impaired and brain function loss and tissue damage occur. During anesthesia in cardiac surgery, inevitable circulatory fluctuations could result in decreasing blood pressure and cerebral blood flow and therefore brain tissue is in ischemia. In this situation the neurovascular regulatory mechanism will function and the brain oxygen saturation also changes based on how this mechanism is influenced. the investigators were devoted to observe how this mechanism was influenced during surgery and how the neural function recovers after surgery so to explore the relationship between them.
详细描述
Preoperative: Routine examinations, including pulse, blood pressure, electrocardiogram, hematological and biochemical tests from blood and urine. Anesthetist paid visit to patient and made judgement whether patient could be included or not based on rating of cognition. Anesthetist also introduced the research plan in detail and patient or guardian signed consent out of participants' own free will.
Intraoperative:
- After admission, the investigators recorded regular vital signs and measured basic cerebral oxygen saturation, then inducted anesthesia.
- After induction the investigators recorded anesthetic dose, vital signs and measured cerebral blood flow and oxygen saturation changes.
- Using BIS to monitor we controlled the anesthesia depth at BIS value of 40 to 60.
- Assuring patient's vital signs to be stable and safe, the investigators gave propofol (3 mg/kg, from Fresenius Kabi) intravenously when BIS was greater than 60 and observed while recorded any changes in BIS value, cerebral blood flow and oxygen saturation.
Postoperative: Patient was transferred to chest surgery ICU and vital signs were recorded.
Clinical data record:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <12 years old
- •Will take cardiac surgery and general anesthesia
- •Cognitive status is normal
- •Cardiac function grade Ⅱ-Ⅲ (using the NYHA cardiac function classification)
排除标准
- •Emergency surgery
- •ASA-V or VI
- •Coagulation disorders,multiple organs dysfunction, endocrine system diseases and severe infectious diseases
- •Patients have been installed pacemakers
- •Suspected or indeed alcohol, drug abuse history
- •Can not cooperate with research, such as the following: language understanding, mental illness, etc.
- •Participated in other clinical trials
- •Perioperative stroke
- •The researchers believe that should not be included in the study
结局指标
主要结局
Thirty of participants with Cognitive function assessment based on "Direction of Chinese Binet Tests (third edition)"
时间窗: 6 months
IQ scores will be used to quantify cognitive function
次要结局
未报告次要终点