Trial document




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  DRKS00005172

Trial Description

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Title

Comparison of different anaesthesia to endourological surgery – a randomised, controlled study.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The choice of an optimal anaesthesia is a task important for both patient and hospital. We do, however, not have enough data to reach such a choice in a way, that minimizes the time a patient spends in a hospital and at the same time ensures his or hers safety and satisfaction. Last but not least we cannot leave the surgeon out of the equation – as his comfort plays is of uttermost importance for the patient. This study should fill this knowledge gap.
In this clinical trial we will compare general (Total Intravenous Anaesthesia – TIVA) with spinal anaesthesia. Both are allowed and carried out by endourologic surgery on a regular basis. The patients will receive one from both anaesthesia forms, and this will be decided by random. This process is generally known as randomisation. There is a 33% chance to receive TIVA.
For spinal anaesthesia we will use either long-acting agent Bupivacain (it provides anaesthesia for 3 -4 hours) or relatively new drug Prilocain (it provides anaesthesia for 1 – 2 hours). The choice will be also done randomly. We will then collect data about anaesthesia time, patients’ satisfaction and complications (such as low blood pressure).

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Brief Summary in Scientific Language

There exist only a handful of studies, in which spinal and general anaesthesia are compared, as of which ensures better patient safety and satisfaction, optimal operation room management and the best operating conditions for surgeon. Also, from 2010 is Prilocain 2% as a hyperbaric solution available. This drug is of great importance in endourological setting, because it is short-acting and has fewer side effects as lidocaine. But there are also only limited number of studies with this drug. A clinical trial, which compares bupivacaine and prilocaine spinal anaesthesia with TIVA is therefore needed.

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Organizational Data

  •   DRKS00005172
  •   2013/10/02
  •   [---]*
  •   yes
  •   Approved
  •   S 17 (a)/2013, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

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Health Condition or Problem studied

  •   Anaesthesia in endourological setting
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Interventions/Observational Groups

  •   Spinal anaesthesie: Prilocain hyperbar (60 mg intrathekal)
  •   Spinal anaesthesie: Bupivacain hyperbar (12,5 mg intrathekal)
  •   TIVA (total intravenous anaesthesia) with mit larynx mask, Remifentanyl (0,5 -1,0 µg/kg/min) and Propofol (4-5 mg/kg/h).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Comparison of the time needed to be able to leave the Post-Anaesthesia Care Unit, based on predefined criteria, between TIVA with Remifentanil and Propofol and spinal anaesthesia done with hyperbaric Prilocain or Bupivacain.

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Secondary Outcome

1. The relation between different anaesthesia forms and patient safety, defined as hemodynamic stability and normal O2 saturation.
2. Side effects:
PONV, low blood pressure, low heart rate, headache, back pain, shivering, vertigo, itching.
3. Patient satisfaction (4 questions, answers are given on a 1 – 5 scale)
3.1. Would You like to have this kind of anaesthesia again?
3.2. Have You experienced unpleasant moments during the surgery?
3.3. Have You felt safe during the surgery?
3.4. How satisfied were You in general with the anaesthesia?
4. Surgeon’s satisfaction (0 – completely unsatisfied, 4 – completely satisfied)
5. Post-operative pain (VAS-Scale) and need for pain-relief drugs. VAS-Scale will be checked every 15 minutes in Post Anaesthesia Care Unit.
6. Cost-analysis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/11/17
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. ASA-Status I-III 2. Planned endourologic surgery 3. Planned surgery time < 60 min

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Exclusion Criteria

1. Absolute contraindication for either TIVA or spinal anaesthesia. 2. Mental handicap. 3. Pregnancy and breastfeeding. 4. Refusal to participate. 5. Refusal to receive one of the proposed anaesthesia forms.

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Addresses

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    • Carl-Thiem Klinikum Cottbus
    • Mr.  PD  Jens  Soukup 
    • Thiemstraße 111
    • 03048  Cottbus
    • Germany
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    • Carl-Thiem Klinikum Cottbus
    • Mr.  Kornel  Skitek 
    • Thiemstraße 111
    • 03048  Cottbus
    • Germany
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    • Carl-Thiem Klinikum Cottbus
    • Mr.  Kornel  Skitek 
    • Thiemstraße 111
    • 03048  Cottbus
    • Germany
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Sources of Monetary or Material Support

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    • Carl-Thiem Klinikum Cottbus
    • Mr.  PD  Jens  Soukup 
    • Thiemstraße 111
    • 03048  Cottbus
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/08/04
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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.