Trial document




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  DRKS00015271

Trial Description

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Title

Evaluation of postoperative cognitive dysfunction in elderly patients after Beach-Chair-Bed

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Trial Acronym

BeachCog

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Since 1998, the general, negative impact of anesthesia and surgery on the brain performance of elderly patients has been known for a limited period of time after surgery.
Certain risk constellations can increase this risk. This may be certain pre-existing conditions, such as circulatory disorders of the carotid arteries but also certain surgical factors. This can be a sitting storage during an operation. Due to gravity, there is a reduced blood flow to the brain.
The purpose of this study is to examine brain performance before and up to 1 month after surgery at three time points with four neurological tests.

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Brief Summary in Scientific Language

Postoperative cognitive dysfunction has been demonstrated in older patients since 1998. There is still no exact identification of individual risk factors. This study aims to investigate cognitive performance before and after surgery on a risk group (older patients in beach chair storage). Four validated neuropsychiatric tests are used for evaluation. By way of comparison, a group of patients with operations on the upper limb in supine position will be evaluated. The primary outcome parameter is the occurrence of postoperative cognitive dysfunction after one week. Secondary parameter is the occurrence after one month.

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Organizational Data

  •   DRKS00015271
  •   2018/10/05
  •   [---]*
  •   yes
  •   Approved
  •   18-558, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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

  •   U51 -  [---]*
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Interventions/Observational Groups

  •   Patients > 60 years with scheduled surgery of the upper extremity in Beach-Chair-Bed.
  •   Patients > 60 years with scheduled surgery of the upper extremity in supine position.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Postoperative cognitive dysfunction after 1 week.
Tests: Wortschatztest, Trail-Making-Test A + B, Regensburger Wortflüssigkeitstest, Letter-Number-Span.
Deterioration of two tests by at least one standard deviation.

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Secondary Outcome

Postoperative cognitive dysfunction after 1 month.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/11/01
  •   114
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Age > 60 years
Planned surgery of upper extremity
Beach-Chair-Bed

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Exclusion Criteria

Age < 60 years
Dementa
Stenosis of aortic valve
Stenosis of carotid artery

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Addresses

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    • Klinik für Anästhesiologie Klinikum der Universität München LMU München
    • Mr.  Dr. med.  Philipp  Groene 
    • Nussbaumstr. 20
    • 80336  München
    • Germany
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    • Klinik für Anästhesiologie Klinikum der Universität München LMU München
    • Mr.  Dr. med.  Philipp  Groene 
    • Nussbaumstr. 20
    • 80336  München
    • Germany
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    • Klinik für Anästhesiologie Klinikum der Universität München LMU München
    • Mr.  Dr. med.  Philipp  Groene 
    • Nussbaumstr. 20
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie Klinikum der Universität München LMU München
    • Mr.  Dr. med.  Philipp  Groene 
    • Nussbaumstr. 20
    • 80336  München
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.