Relationship Between Cognitive Function and Pain
Cognitive Function in Healthy Volunteers Exposed to Acute Pain Before and After Administration of Remifentanil
Patients with chronic pain can experience considerable changes in their cognitive function such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead to worsening of the cognitive function. The interaction between pain, treatment and cognitive function is very complex and is far from understood.
The hypothesis of the present study is that by use of experimental pain in healthy volunteers it will be possible to elucidate the interaction between pain, treatment and cognitive function.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Aalborg、丹麦、9000
- Mech-Sense, Department of Gastroenterology, Aalborg Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy men aged 18-65 years
- Normal vision and hearing
- No disease associated with cognitive dysfunction
Exclusion Criteria:
- Allergic to remifentanil or patches
- Any use of pain killers or alcohol 48hours before study start
- Current participation in other clinical studies or participation within the last 14days before study start
- Prescribed medication
- Risk of developing
- Previously alcohol- or drug addict
- MMSE score < 26
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Remifentanil
Investigate the effect of remifentanil on cognitive function in healthy volunteers by use of experimental pain models:
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0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
其他名称：
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安慰剂比较：Placebo infusion
To blind the study and use as comparator in the investigation of the effect of remifentanil on cognitive function in healthy volunteers by use of experimental pain models:
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0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Cognitive function
大体时间：3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month
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Investigate the relationship between cognitive function and pain and treatment with remifentanil
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3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Ultiva (remifentanil) or placebo的临床试验
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Fundación Universitaria de Ciencias de la SaludHospital de San Jose完全的