Trial document





This trial has been registered retrospectively.
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  DRKS00004906

Trial Description

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Title

The spinal anesthesia with hyperbaric Lokalanästhestikum performed in the lateral position, compared to general anesthesia in outpatient anesthesia, in terms of effectiveness, process times, hemodynamic stability, perioperative complications, and postoperative pain

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Trial Acronym

ESG-unilaterSPA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study, the method of unilateral spinal anesthesia should be investigated in orthopedic outpatient surgery. The effectiveness of unilateral spinal anesthesia is checked by measuring the resistance of the skin and determines its spread. Are investigated complications of the procedure.

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Brief Summary in Scientific Language

This study will examine how the use of spinal anesthesia with hyperbaric lokalanästhetics performed in the lateral position, effect compared to general anesthesia in outpatient anesthesia. Both process times, the efficacy / objectification with the ESG spinal anesthesia, the hemodynamic stability during anesthesia and in the recovery room, as well as possible complications during anesthesia and in the recovery room to be examined. Furthermore, patients are interviewed using a standardized questionnaire postoperatively to your satisfaction, intraoperative and postoperative pain and the use of postoperative analgesics

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Organizational Data

  •   DRKS00004906
  •   2013/04/30
  •   [---]*
  •   yes
  •   Approved
  •   29/11/10, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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

  •   M23 -  Internal derangement of knee
  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   Anesthetic procedures: spinal anesthesia with hyperbaric bupivacaine 0.5% in lateral position: completely objective, sympathetic unilateral spinal anesthesia for ambulatory surgery on the knee joint monitoring with skin resistance measurement with the ICM (electric sympatho graph)
  •   Anesthetic procedures:General anesthesia with remifentanil and propofol for laryngeal mask airway management outpatient orthopedic surgery on knee
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

1 Process times SPA vs. general an.
- Time to implement the spinal anesthesia /general anesthesia., beginning OP
- Time seam, recovery
- Dismissal time recovery
- Staff retention time recovery
2 Unilateral spinal anesthesia, by testing the sensory / motor blockade
- Objective testing with measurement of sympatic activity by measuring the skin conductance (ESG-Electric sympatho graphy)


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Secondary Outcome

perioperative complications - anesthetic protocol
postoperative pain - Questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/04/01
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Be included in the study 120 male or female patients who undergo elective outpatient arthroscopy of the knee joint. This included 60 patients who received anesthesia as a unilateral spinal anesthesia and 60 patients receiving general anesthesia

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Exclusion Criteria

Unsuitability for the anesthetic procedure

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Addresses

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    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • 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.