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临床试验/NCT01375348
NCT01375348
已完成
3 期

Cognitive Function in Healthy Volunteers Exposed to Acute Pain Before and After Administration of Remifentanil

University of Aarhus1 个研究点 分布在 1 个国家目标入组 23 人2011年6月

概览

阶段
3 期
干预措施
Ultiva (remifentanil) or placebo
疾病 / 适应症
Cognitive Ability, General
发起方
University of Aarhus
入组人数
23
试验地点
1
主要终点
Cognitive function
状态
已完成
最后更新
14年前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2011年6月
结束日期
2012年2月
最后更新
14年前
研究类型
Interventional
研究设计
Crossover
性别
Male

研究者

责任方
Sponsor

入排标准

入选标准

  • Healthy men aged 18-65 years
  • Normal vision and hearing
  • No disease associated with cognitive dysfunction

排除标准

  • 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

研究组 & 干预措施

Remifentanil

Investigate the effect of remifentanil on cognitive function in healthy volunteers by use of experimental pain models: * tonic muscle pain induced by the tourniquet pain model * cognitive tests * recording of brain activity by use of 64 channel cap

干预措施: Ultiva (remifentanil) or placebo

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: * tonic muscle induced pain by the tourniquet pain model * cognitive tests * brain activity by use of a 64 channel cap

干预措施: Ultiva (remifentanil) or placebo

结局指标

主要结局

Cognitive function

时间窗: 3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month

Investigate the relationship between cognitive function and pain and treatment with remifentanil

研究点 (1)

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