Trial document





This trial has been registered retrospectively.
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  DRKS00004907

Trial Description

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Title

Observational study: influence of ketamine for ambulatory shoulder surgery. Comparison of two anesthetic procedures established in terms of processing time, hemodynamic stability, patient satisfaction and postoperative pain

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Trial Acronym

Outpatient ketanest

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this observational study, two established methods are compared anesthesia in outpatient practice in terms of processing time, hemodynamic stability, patient satisfaction and postoperative pain. In the studied outpatient facility anesthesia are performed for shoulder surgery. These are carried out either as an opiate / anesthetic propofol, ketamine or additionally applied to provide a greater hemodynamic stability during storage of the sitting operation, and to achieve a preventive analgesia postoperatively.

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Brief Summary in Scientific Language

Comparison of anesthesia TIVA with remifentanil / propofol anesthesia with TIVA with remifentanil / propofol / ketanest. The ketanest is administered before the outpatient shoulder arthroscopy patient sits up into the beach chair position. We examine the process times, patient satisfaction, hemodynamic stability, and postoperative pain.

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Organizational Data

  •   DRKS00004907
  •   2013/04/30
  •   [---]*
  •   yes
  •   Approved
  •   6/9/11, 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

  •   M75.4 -  Impingement syndrome of shoulder
  •   M75.1 -  Rotator cuff syndrome
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Interventions/Observational Groups

  •   Anesthetic procedures: total intravenous anesthesia (TIVA) with propofol + remifentanil
    > measuring of: process times, hemodynamic stability, patient satisfaction and postoperative pain, and the incidence of complications.
  •   Anesthesia: TIVA with propofol + remifentanil + ketanest
    > measuring of: process times, hemodynamic stability, patient satisfaction and postoperative pain, and the incidence of complications ..
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, assessor
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Process times / During anesthesia measured
- Time eye opening to speech
- Time to extubation
- time to admission to recovery room
- time to discharge from recovery room
Hemodynamic parameters - stability / measured during anesthesia and recovery room
- Blood pressure, HR, SaO2, EtCO2
- Infusion volume
- Circulatory supportive medication

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Secondary Outcome

Postoperative pain (in the recovery room, day surgery in the evening, on postoperative day 1, the second postoperative day)
- Satisfaction with anesthesia / questionnaire
- Amount of postoperative analgesics
Postoperative Complications
- PONV
- Anti-cholinergic syndrome
- Shivering
- Sore throat, hoarseness, difficulty swallowing
Anesthetics consumption - anesthesia protocol

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/02/01
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

In this study 300 male and female patients will be enrolled. In the patients is elective outpatient surgery of the shoulder performed here is one of the above two anesthetic procedures performed. Another criterion for inclusion is the ability to consent of the patients.

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Exclusion Criteria

no consent
no aptitude for the anesthesia procedure

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Addresses

  • start of 1:1-Block address primary-sponsor
    • 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 complete, follow-up complete
  •   2013/11/01
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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.