Trial document




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  DRKS00009312

Trial Description

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Title

TCI Performance after major surgery

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

TCI (target controlled infusion) is a modern concept for dosing of Propofol during anesthesia. TCI-systems are based on weight, hight, age and sex of patients but do not consider anesthesia conduction. TCI-predicted propofol plasma level will be compared to real propofol plasma level at the beginning and at the end of major surgery.

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Brief Summary in Scientific Language

TCI (target controlled infusion) is a modern concept for dosing of Propofol during anesthesia. TCI-systems are based on weight, hight, age and sex of patients but do not consider anesthesia conduction. TCI-predicted propofol plasma level will be compared to real propofol plasma level at the beginning and at the end of major surgery.

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Organizational Data

  •   DRKS00009312
  •   2015/09/02
  •   [---]*
  •   yes
  •   Approved
  •   KEKTGOV2015/09, Kantonale Ethikkommission Thurgau
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Secondary IDs

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Health Condition or Problem studied

  •   Patients undergoing surgery in (Propofol-) general anesthesia
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Interventions/Observational Groups

  •   Assessment of propofol Plasma Level at the beginning and at the end of major surgery
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Difference predicted TCI value to real Plasma level

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Secondary Outcome

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/09/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Adult patients (18-70 years) undergoing major surgery at the Kantonsspital Frauenfeld in propofol based general anesthesia with intraarterial blood pressure Monitoring according to institutional standard.

Major surgery: expected blood loss > 1000 ml (Group 1) or expected duration of surgery > 180 min and expected amount of infusion > 2500 ml (Group 2).

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Exclusion Criteria

BMI (kg/m2) < 20 or > 35. Allergic to propofol. Emergency surgery. Pregnancy. Known or suspected liver disease.

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Addresses

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    • Institut für Anästhesie und IntensivmedizinKantonsspital Frauenfeld
    • Mr.  PD Dr.  Alexander  Dullenkopf 
    • Postfach
    • 8501  Frauenfeld
    • Switzerland
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    • Institut für Anästhesie und IntensivmedizinKantonsspital Frauenfeld
    • Mr.  PD Dr.  Alexander  Dullenkopf 
    • Postfach
    • 8501  Frauenfeld
    • Switzerland
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    • Institut für Anästhesie und IntensivmedizinKantonsspital Frauenfeld
    • Mr.  PD Dr.  Alexander  Dullenkopf 
    • Postfach
    • 8501  Frauenfeld
    • Switzerland
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Sources of Monetary or Material Support

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    • Institut für Anästhesie und IntensivmedizinKantonsspital Frauenfeld
    • Postfach
    • 8501  Frauenfeld
    • Switzerland
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/10/31
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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.