Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010698

Trial Description

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Title

optimizing of the intraoperative application of fentanyl during liver transplantation

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Trial Acronym

[---]*

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URL of the Trial

http://nicht vorhanden

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Brief Summary in Lay Language

Fentanyl is the most frequently used analgetic drug for anesthesia during liver transplantation. The metabolization of this drug is not only influenced by the diseased liver but also by the various phases of the operation. That is why it makes sense to measure fentanyl’s plasma levels during liver transplantation. The goal of this study is to develop an infusion regime allowing a repid recovery.
Patients undergoing elective liver transplantation are randomly divided in two groups. The first group receive fentanyl only during the preparation phase (paleohepatic group), whereas the second group get fentanyl until finishing the suture of the arteria hepatica. Blood samples are taken at specific measurement points to analyze the fenanyl’s plasma levels.

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Brief Summary in Scientific Language

In contrast to general surgery the pharmacokinetic of fentanyl, which is frequently used for anesthesia during orthotopic liver transplantation (OLT), is not only influenced by the diseased liver but also by the various phases (paleo-, an- and neohepatic) of the operation. Both affect the pharmacokinetic of fentanyl during OLT.
That is why during OLT fentanyl’s plasma levels are measured. The goal of the study is to develop an infusion regime allowing a rapid recovery.
Patients undergoing elective OLT are randomly divided into two groups. One group receive fentanyl only during the paleohepatic phase (paleohepatic group), whereas the other group get fentanyl until anastomose of the A. hepatica had been completed (anhepatic group).
A specific monitoring of fentanyl’s pharmacodynamics is currently not available. In addition, in patients with an impaired metabolic capacity of the liver or due to the characteristics of OLT with its anhepatic phase predicting fentanyl’s action remains an exceptional challenge.
Knowing the plasma concentration of fentanyl during OLT would help the anesthetist to better balance anesthesia.

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Organizational Data

  •   DRKS00010698
  •   2016/08/31
  •   [---]*
  •   yes
  •   Approved
  •   092-2007, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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

  •   K72.0 -  Acute and subacute hepatic failure
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Interventions/Observational Groups

  •   continuous application of fentayl with 3µg/kg/h with start at the beginning of the anaesthsia and stop with beginning of the anhepatic turn during the surgery
  •   continuous application of fentayl with 3µg/kg/h with start at the beginning of the anaesthsia and stop with te finish of the arterial anastomosis during the surgery
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Level of fentanyl in plasma at the end of the Operation and the possibility of extubation

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Secondary Outcome

not availabe

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2007/03/29
  •   22
  •   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

liver transplantation

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Exclusion Criteria

informed consent missing
drug abuse
acute kidney failure
anaesthesia with using other volatila anaesthetics than isoflurane
acute infection (fever or SIRS positive)
> 20h cold ischemia of the donor organ

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Addresses

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    • Universitätsklinikum Leipzig
    • Liebigstr. 18
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig
    • Liebigstr. 18
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Leipzig, AöR
    • Ms.  Dr. med.  Uta-Carolin  Pietsch 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Klini und Poliklinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Leipzig, AöR
    • Ms.  Dr. med.  Uta-Carolin  Pietsch 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Leipzig, AöR
    • Liebigstraße 18
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2009/05/21
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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.