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临床试验/NCT01184638
NCT01184638Unknown4 期

Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
10,000
试验地点
1
主要终点
Cognitive ability

研究概览

简要总结

Cognitive disorders in patients underwent general anesthesia are discussed for decades, but whether there were precise relationship between general anesthesia and dysgnosia is yet to be guaranteed. Although controversial data reported from experimental studies in animals, the investigators still proposed that general anesthetics could impair the normally organized system of the central nervous system, which finally displayed a dysfunction of cognition after general anesthesia in a short- or long-term period. Therefore, different types of general anesthetics such as inhalational anesthetics and intravenous anesthetics, the investigators hypothesized, had a long-term influence on patients' cognitive ability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with informed consents
  • Without basal disorders of neurology and psychiatrics

排除标准

  • With the history of cognitive disorders
  • With chronic neurological disorders
  • Cannot communicate with investigators
  • Cannot stand general anesthesia

研究组 & 干预措施

Inhalational anesthesia

Active Comparator

Patients received sevoflurane anesthesia during general anesthesia

干预措施: Sevoflurane (Drug)

Intravenous anesthesia

Active Comparator

Patients received intravenous anesthetic (Propofol) during general anesthesia

干预措施: Propofol (Drug)

结局指标

主要结局

Cognitive ability

时间窗: The 10th year since postoperation

Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory

次要结局

  • Cognitive ability(Once a year from the 1st year after operation up to 9th year)

研究者

发起方
Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fu Zhou Wang

Dr

Nanjing Medical University

研究点 (1)

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Long-term Outcome of General Anesthesia on Dysgnosia | 临床试验