Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
23 participants
INTERVENTIONAL
2011-06-30
2012-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DOUBLE
Study Groups
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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
Ultiva (remifentanil) or placebo
0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
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
Ultiva (remifentanil) or placebo
0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
Interventions
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Ultiva (remifentanil) or placebo
0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal vision and hearing
* No disease associated with cognitive dysfunction
Exclusion Criteria
* 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
18 Years
65 Years
MALE
Yes
Sponsors
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Mech-Sense
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Asbjørn M Drewes, Professor
Role: PRINCIPAL_INVESTIGATOR
Mech-Sense
Locations
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Mech-Sense, Department of Gastroenterology, Aalborg Hospital
Aalborg, , Denmark
Countries
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References
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Graversen C, Malver LP, Kurita GP, Staahl C, Christrup LL, Sjogren P, Drewes AM. Altered frequency distribution in the electroencephalogram is correlated to the analgesic effect of remifentanil. Basic Clin Pharmacol Toxicol. 2015 May;116(5):414-22. doi: 10.1111/bcpt.12330. Epub 2014 Oct 21.
Other Identifiers
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Kogprem
Identifier Type: -
Identifier Source: org_study_id
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