Trial document





This trial has been registered retrospectively.
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  DRKS00012961

Trial Description

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Title

Influence of benzodiazepines and propofol on epigenetic modifications in immune cells and their influence on postoperative cognitive dysfunction

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Many people suffer from memory disturbances after surgery. The reason for this is on the one hand anesthesia per se, but also the inflammatory reaction, which is triggered in the body by the surgical procedure. At present little is known about, why some people develop a memory disorder after surgery and others do not. Possibly, genetic factors play a role here. We therefore want to examine in the study whether changes in the DNA structure can be responsible for the occurrence of memory disturbances. In addition, we will investigate whether certain narcotic agents themselves can alter the DNA structure.
We take whole blood from healthy volunteers and stimulate this with the anesthetics propofol and midazolam and induce inflammation. Then we study changes in the DNA structure.

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Brief Summary in Scientific Language

The aim of the study is to evaluate whether certain anesthetics can lead to epigenetic changes in humans. Furthermore, it is investigated whether the epigenetic mechanisms possibly influence genes of the neurological system and lead to long lasting changes. In addition, the study will investigate how the inflammatory reaction of the body, which frequently occurs during surgery, can be optimally inhibited. The results of this study can help to reduce the risk of an anesthesia induce POC and possibly show therapeutic options and help develop a biomarker for the rapid diagnosis of POCD.

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Organizational Data

  •   DRKS00012961
  •   2018/06/19
  •   [---]*
  •   yes
  •   Approved
  •   17-5964, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   healthy subjects
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Interventions/Observational Groups

  •   After written informed consent, 90 ml of venous whole blood is collected in EDTA monovettes from 20 healthy volunteers. This is stimulated with different anesthetics (propofol, midazolam, other benzodiazepines), inflammatory agents (TNF-α, LPS), as well as immunomodulatory agents (hydrocortisone, sulfonamides, phytochemicals). In addition, a control without stimulation is used. After 2, 4 and 24 hours of incubation, the separation of, neutrophils, lymphocytes and monocytes, as well as the asservation of the blood plasma takes place. The cells are used to isolate RNA, DNA and histones. This is followed by an investigation of the expression of various genes after reverse transcription, as well as the DNA methylation analysis after bisulfite treatment and the examination of the histone modifications by means of ELISA.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Understanding the pathophysiology of POCD by measuring the expression of enzymes that regulate epigenetic mechanisms after stimulating whole blood samples with different anesthetics. Analysis of epigenetic markers such as DNA methylation, acetylation and histone modifications after anesthetic stimulation.

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Secondary Outcome

developement of biomarkers for POCD.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/05/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

healthy, no infection

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Exclusion Criteria

infection, anemia

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Knappschaftskrankenhaus Bochum
    • Mr.  Prof.  Michael  Adamzik 
    • In der Schornau 23-25
    • 44892  Bochum
    • Germany
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    • Ruhr Universität Bochum Knappschaftskrankenhaus Bochum Klinik für Anästesiologie
    • Ms.  Dr.  Katharina  Rump 
    • Universitätsstraße 150
    • 44801  Bochum
    • Germany
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    • Ruhr Universität Bochum Knappschaftskrankenhaus Bochum Klinik für Anästesiologie
    • Ms.  Dr.  Katharina  Rump 
    • Universitätsstraße 150
    • 44801  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Knappschaftskrankenhaus Bochum
    • Mr.  Prof.  Michael  Adamzik 
    • In der Schornau 23-25
    • 44892  Bochum
    • 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.