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临床试验/NCT00297245
NCT00297245Unknown4 期

Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年2月最近更新:
适应症
相关药物

试验速览

阶段
4 期
入组人数
200
试验地点
1
主要终点
Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass

研究概览

简要总结

The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance.However, there is no method to prevent the decline.Gastrodin,the active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and Alzheimer's disease. Gastrodin is safe. No severe side-effect has been observed in the treatment. We postulate that gastrodin would attenuate the causative parameters of cognitive dysfunction related to CPB and would be an effective drug to prevent the decline as a result.

详细描述

Cardiac surgery with cardiopulmonary bypass (CPB) is one of the most frequently performed operations. Neurobehavioral disorders, including neuropsychiatric and neuropsychological deficits, are a very frequently reported sequela of valve replacement or coronary artery bypass grafting (CABG) surgery. CPB is associated with significant cerebral morbidity. The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance. Neurocognitive decline can present days to weeks after surgery and may remain a permanent disorder. Many pharmacologic strategies have been proposed or investigated for preventing post-CPB cognitive decline, but to our knowledge, none of these drugs has been systematically evaluated for efficacy in preventing post-CPB cognitive decline.

The causative parameters of cognitive dysfunction associated with CPB include cerebral ischemia secondary to either microemboli or hypoperfusion, intraoperative cerebrovascular risk factors such as the duration of CPB, inflammatory response, cerebral glutamine release, free radicals, and NO release.

Gastrodia elata, a famous Chinese medical herb, has effects on preventing ischemic brain injury, neuronal cell damage or apoptosis, suppressing inflammatory response, inhibiting glutamine receptors and nNOS, and scavenging free radicals. Gastrodin (4-[hydroxymethyl]phenyl-β-D-glucopyranoside), the primary active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and Alzheimer's disease. Based on its pharmacological effects, we postulated that gastrodin would attenuate the causative parameters of cognitive dysfunction related to CPB and would be an effective drug to prevent the decline as a result.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

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

  • Adult patients undergo mitral valve replacement surgery.

排除标准

  • Thrombi in left atrium, a history of symptomatic cerebrovascular disease, diabetes, psychiatric illness, renal disease, or active liver disease, less than a seven-grade education, or who cannot read.

结局指标

主要结局

Gastrodin markedly prevents cognitive decline related to cardiopulmonary bypass

次要结局

  • neuropsychological tests

研究者

研究点 (1)

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