Trial document




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  DRKS00005661

Trial Description

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Title

In vivo assessment of membraneexcitability changes due to Propofolmedication in motor nerve and skelettmuscle

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Trial Acronym

Pro-TROND

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We like to assess, if Propol anesthesia will cause reduced membrane excitability in muscle fibre and motor nerve in vivo.

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Brief Summary in Scientific Language

Objective: To assess in vivo membrane excitability changes in motor nerve and muscle fibers caused by i.v. Propofol administration. Recent studies have shown reduced membrane excitability in vitro in motor nerve [Rehberg et al. 1999] and in muscle fibres [Haeseler et al. 2001] by disable voltage-gated sodium channels after Propofol applications. Threshold tracking is a neurophysiological Method to assess in vivo membrane excitability in motor nerve [Kiernan and Bostock 2000] and in muscle fiber [Z'Graggen and Bostock 2009]. This methode will be execute in Patients, with planed operation and the need of a Propofol application for anesthesia.

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Organizational Data

  •   DRKS00005661
  •   2014/11/14
  •   [---]*
  •   yes
  •   Approved
  •   EA1/005/14, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   healthy patients (ASA I and II) with planed, small operation
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Interventions/Observational Groups

  •   Arm 1 - membrane excitability testing with "threshold tracking" in motor nerve before and after Propofol administration
  •   Arm 2 - membrane excitability testing with "threshold tracking" in scelett muscle fibres before and after Propofol administration
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Membraneexcitability changes assessed by "Threshold tracking" of motor nerve / muscle fibres before and after Propofol administration

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Secondary Outcome

Concentration of electrolytes before and after administration of Propofol. Propofolconcentration after induction of anesthesia. Korrelation with membraneexcitability changes in motor nerve / muscle fibres before and after Propofoladministarion.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/15
  •   40
  •   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

planed operation with Propofol anesthesia

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Exclusion Criteria

neuro-muscular diseases

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Addresses

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Campus Virchow-Klinikum
    • Ms.  Dr.  Susanne  Koch 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Campus Virchow-Klinikum
    • Ms.  Dr  Susanne  Koch 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.