Relationship Between Cognitive Function and Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Cognitive Ability, General

Intervention / Treatment
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* Drug: Ultiva (remifentanil) or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remifentanil<br>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 | Drug: Ultiva (remifentanil) or placebo<br>* 0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min<br>* Other names: Ultiva (remifentanil);|
| Placebo Comparator: Placebo infusion<br>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 | Drug: Ultiva (remifentanil) or placebo<br>* 0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min<br>* Other names: Ultiva (remifentanil);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Investigate the relationship between cognitive function and pain and treatment with remifentanil | 3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive function, Experimental pain