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Relationship Between Cognitive Function and Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01375348
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : February 14, 2012
Sponsor:
Collaborator:
Mech-Sense
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE June 15, 2011
First Posted Date  ICMJE June 17, 2011
Last Update Posted Date February 14, 2012
Study Start Date  ICMJE June 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2011)
Cognitive function [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relationship Between Cognitive Function and Pain
Official Title  ICMJE Cognitive Function in Healthy Volunteers Exposed to Acute Pain Before and After Administration of Remifentanil
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Cognitive Ability, General
Intervention  ICMJE Drug: Ultiva (remifentanil) or placebo
0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
Other Name: Ultiva (remifentanil)
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Drug: Ultiva (remifentanil) or placebo
  • Placebo Comparator: 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
    Intervention: Drug: Ultiva (remifentanil) or placebo
Publications * Graversen C, Malver LP, Kurita GP, Staahl C, Christrup LL, Sjøgren 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2012)
23
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2011)
20
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01375348
Other Study ID Numbers  ICMJE Kogprem
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Mech-Sense
Investigators  ICMJE
Principal Investigator: Asbjørn M Drewes, Professor Mech-Sense
PRS Account University of Aarhus
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP