Trial document





This trial has been registered retrospectively.
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  DRKS00005260

Trial Description

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Title


ß2-Adrenoceptor Gene Variants and Vasopressor Requirements in Patients following Thoracic Epidural Anaesthesia

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Trial Acronym

ADRB2 variants and hypotension following TEA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is intendend to investigate whether genetic gene variants affect the need of vasoactive substances after initiation of a thoracic epidural anaesthesia.
Patients for upper abdominal surgery to undergo a so-called epidural. By this method, we reduce the postoperative pain but is also the cardiovascular system affected by the regulation of blood pressure is reduced. Of this patient's blood is removed and there are genetic variations in the signal path, which is important studied for blood pressure regulation. These variants come in three versions with different frequency before, with the lowest Frequency reading at 25%. Hence arise three groups and these groups are examined for the blood pressure variation.

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Brief Summary in Scientific Language

While the β2-adrenoceptor pathway is essential for cardiovascular regulation, the impact of ADRB2 gene variations on circulatory responses is unclear, possibly due to neural compensatory mechanisms. We want to test the hypotheses, that 1) sympathetic blockade by thoracic epidural anaesthesia (TEA) unmasks the influence on arterial pressure of genetic variations, and 2) vasopressor requirements during TEA depend on ADRB2 gene variation.

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Organizational Data

  •   DRKS00005260
  •   2013/09/26
  •   [---]*
  •   yes
  •   Approved
  •   038/03, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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

  •   epidural anaesthesia
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Interventions/Observational Groups

  •   It is a genetic observational study. For the study participants, blood is removed and the patient be genotyped the ADRB2 genotypes. There arise from 3 arms with the respective genotypes. blood pressure and vasopressor requirements will be determined in all arms.
    Arm1: Arg16Arg
  •   Arg16Gly
  •   Gly16Gly
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Pharmacogenetics
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Vasopressor requirements after TEA ( thoracic epidural anaesthesia)

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Secondary Outcome

no

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/04/01
  •   92
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

hepatectomy, liver resection, gastrectomy, and Whipple operation

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Exclusion Criteria

American Society of Anesthesiologists physical status IV, severe coronary heart disease, high-grade valvular stenosis/insufficiency, cardiac failure, pulmonary hypertension, right ventricular failure, chronic respiratory insufficiency, coagulopathy, anticoagulant medication, or refusal of epidural anaesthesia.

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Addresses

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    • UK Essen
    • Mr.  PD Dr. med.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • UK Essen
    • Mr.  PD Dr. med.  Ulrich  Frey 
    • hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address scientific-contact
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    • UK Essen
    • Mr.  PD Dr. med.  Ulrich  Frey 
    • hufelandstr. 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • UK Essen
    • Mr.  PD Dr. med.  Ulrich  Frey 
    • hufelandstr. 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/08/23
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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.