Trial document





This trial has been registered retrospectively.
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  DRKS00003062

Trial Description

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Title

Pain monitor in the intensive care medicine

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Trial Acronym

Schmemo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study the threshold of a flexor reflex is tested as a tool to predict diverse reactions to painful stimuli in sedated patients in the intensive care unit. Therefore we examine the correlation between the flexor reflex threshold and the reactions to painful stimuli. A good correlation would allow to use the reflex threshold as an objective parameter to support the dosing of the analgesic therapy which is usually done by subjective observational parameters.
The inclusion in the study is restricted to patients that can give written formal consent prior to their stay in the intensive care unit. These are patients that receive elective surgical procedures which necessitate a postoperative sedation within an intensive care unit environment(i.e. cardio-surgical interventions).
The primary aim of this study is testing the hypothesis that an inadequate analgesia can be detected by measuring the RIII-reflex threshold before a painful stimulation.

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Brief Summary in Scientific Language

The fact that 33-55% of ICU patients report severe pain after an ICU stay while physicians and nurses underestimate this issue and therefore treat pain inadequately, underlines the necessity to monitor analgesia more efficiently. Inadequate pain therapy may lead to agitation in patients that may result in life-threatening situations such as self-extubation, removal of catheters or the increase of myocardial oxygen consumption with consecutive myocardial infarction. It appears possible, that measuring the RIII reflex threshold could help to improve the dosing of the analgesic drugs (opioids) before a painful therapeutic intervention and therefore help to reduce the effects or under-dosing that might lead to agitation.
Adequate dosing of opioids in deeply sedated non-communicative patients is extremely difficult since observational pain scales indicate falsely lower values with increasing depth of sedation. The usefulness of these observational pain scales is therefore very limited in deeply sedated patients. In those patients, a regular measurement of the RIII reflex threshold could be helpful to monitor the analgesic therapy and adapt its dosing. This could not only avoid over- of the drugs and its consequences such as prolonged ventilation time or a prolonged ICU stay, but also under-dosing and its above mentioned consequences. The additional more objective monitoring of the RIII-Reflex threshold also directly visualizes the effects of dosing chanages to the ICU personnel and might therefore increase the vigilance to pain-therapy in sedated individuals.
The primary aim of this study is testing the hypothesis that an inadequate analgesia (defined as behavioral pain scale score >6) can be detected by measuring the RIII-reflex threshold before a this painful stimulation.

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Organizational Data

  •   DRKS00003062
  •   2011/08/08
  •   [---]*
  •   yes
  •   Approved
  •   EA2/118/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Analgo-sedated patients in the ICU
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   The RIII-reflex threshold is measured preoperatively to obtain baseline values for each individual patient. Therefore the RIII-reflex is stimulated via surface electrodes over the sural nerve at the ankle. The reflex response is recorded as an electormyographic wave over the biceps femoris muscle of the ipsilateral leg. The Stimulation current is adapted close to the threshold (5-100mA). Immediately prior to painful procedures in sedated patients (tracheal suctioning, Drainage removal, electrical tetanic stimulation at the wrist 80mA 50 Hz) the RIII-reflex threshold is measured and the behavioral pain score (BPS) is evaluated. During the painful stimulation the BPS is also registered.
    In awake subjects the patient is asked to estimate their pain level (NRS-score 1-10) before the RIII-reflex threshold is measured.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Predictability of Behavioral pain scale score >6 by using the RIII-Reflex threshold

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Secondary Outcome

Predictability of inadequate analgesia defined as an NRS>4 in awake ICU patients by using the RIII-reflex threshold

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/08/13
  •   140
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

legal age, patients that receive surgery for which a postoperative sedation is planed. Patients have to give consent preoperatively.

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Exclusion Criteria

Damages or severe Neuropathies of peripheral nerves of the lower limb, Patients with ICD or pacemaker.

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Addresses

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    • Charité Universitätsmedizin Berlin Klinik für Anästhesiologie Campus Charité Mitte
    • Mr.  Priv.-Doz. Dr. med.  Jan H.  Baars 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Campus Charité Mitte
    • Mr.  Priv.-Doz. Dr. med.  Jan  Baars 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Campus Charité Mitte
    • Mr.  Priv.-Doz. Dr. med.  Jan H.  Baars 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Wirtschaft und Technologie
    • Scharnhorststr. 34-37
    • 10115   Berlin
    • Germany
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    •   +49 30- 18 615 0
    •   +49 30- 18 615 7010
    •   [---]*
    •   http://www.bmwi.de
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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/10/14
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Trial Publications, Results and other Documents

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