Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006477

Trial Description

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Title

Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations in Patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Propofol can be measured continuously in breath gas during anesthesia. This study compares
propofol concentration in plasma and breath gas and processed electroencephalographic
monitoring (bispectral index) under clinical conditions with patients and total intravenous
anesthesia. Target controlled infusion technique is used to deliver adequate propofol
concentration in plasma.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006477
  •   2014/11/05
  •   2013/04/15
  •   yes
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Secondary IDs

  •   NCT01835340  (ClinicalTrials.gov)
  •   NCT01191021  (University of Luebeck)
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Health Condition or Problem studied

  •   Urological Disease
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Interventions/Observational Groups

  •   Device: Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
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Primary Outcome

- Exhaled propofol (parts per billion); time frame: Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/10/31
  •   30
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Inclusion Criteria

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

• 18 years of age

- Written informed consent

- Ability and willingness to give written informed consent

- American Society of Anesthesiologists (ASA) risk score I-II

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Exclusion Criteria

- Denial of the patient

- Patients ASA physical status III- IV

- Pregnancy

- Volunteers with history of neurological disease or stroke

- Volunteers with a history of recreational drug abuse

- Volunteers with a history of alcohol abuse

- Known drug allergies

- History of adverse events during general anesthesia

- Total intravenous anesthesia not practicable

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Addresses

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    • University of Luebeck
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    • Draeger
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    •   [---]*
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    • University of Luebeck
    • Hartmut Gehring, Professor 
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    • University of Luebeck
    • Hartmut Gehring, Professor 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Igl BW, Ziegler A, Schmucker P, Gehring H. Propofol concentration in exhaled air and arterial plasma in mechanically ventilated patients undergoing cardiac surgery. Br J Anaesth. 2009 May;102(5):608-13. doi: 10.1093/bja/aep053. Epub 2009 Mar 31.; 19336539
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2015/10/22
* This entry means the parameter is not applicable or has not been set.