Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00008736

Trial Description

start of 1:1-Block title

Title

Midazolam plasma concentration in children after anesthesia premedication in clinical routine

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Midazolam is a standard drug for premedication in children undergoing anesthesia.
There are few data about resulting plasma levels at anesthesia induction and at the end of short procedures.
In this study 20 children will be premedicated as usual. Upon the induction of anesthesia and at the end of surgery (max. duration 30 min), midazolam plasma levels will be assessed.
Parents and anesthetist rate the level of sedation, the parents rate their satisfaction with premedication.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

20 children (patients) aged 2-8 years undergoing surgery in general anesthesia will be routinely premedicated with midazolam rectally 0.5 mg/kg about 30 min Prior to anesthesia.
Upon arrival in the OR the Level of sedation will be assessed by OAA/S (observer`s assessement of alertness/sedation score; 0-20). Induction of anesthesia will be by inhalation. With the child asleep, intravenous canulation will be performed and 3 ml blood drawn. Same will be done at the end of surgery. Plasma Levels will be analyzed in the Institute for clinicalchemistry, University Zurich by HPLC mass spectrometry. At the first post-OP day parents will be asked to rate the level of sedation (VAS 0-10) and their satisfaction with premedication (0-10).

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008736
  •   2015/06/03
  •   [---]*
  •   no
  •   Approved
  •   KEKTGAE2014/16, Kantonale Ethikkommission Thurgau, Münsterlingen, Schweiz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Children undergoing surgery in General anesthesia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Premedication as clinically usual. Measurement of midazolam plasma level at induction of anesthesia and at the end of surgery. Rating of sedation level by anesthetist and parents. Rating of satisfaction by parents.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   IV
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Midazolam plasma Levels at induction of anesthesia and at the end of operations.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Level of sedation upon arrival in the OR (OAA/S). Next day: Rating of sedation level (VAS) and of satisfaction with premedication (VAS) by parents.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/08/01
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   8   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Elective surgery in general anesthesia, estimated Duration of surgery less than 31 min, midazola 0.5 mg/kg clinically indicated, written informed parental consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Allergy to any used substances, severe respiratory/neurological/liver/kidney(gastro-intestinal Problems, medication known to interfere with midazolam pharmakocinetics, OSAS, application of midazolam during study period other than per study protocol.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Anästhesie und IntensivmedizinKantonsspital Frauenfeld
    • Mr.  PD Dr.  Alexander  Dullenkopf 
    • Postfach
    • 8501  Frauenfeld
    • Switzerland
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institut für Anästhesie und IntensivmedizinKantonsspital Frauenfeld
    • Mr.  PD Dr.  Alexander  Dullenkopf 
    • Postfach
    • 8501  Frauenfeld
    • Switzerland
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Anästhesie und IntensivmedizinKantonsspital Frauenfeld
    • Mr.  PD Dr.  Alexander  Dullenkopf 
    • Postfach
    • 8501  Frauenfeld
    • Switzerland
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Institut für Anästhesie und IntensivmedizinKS Frauenfeld
    • Mr.  PD Dr.   Alexander  Dullenkopf 
    • Pfaffenholzstr. 4
    • 8501  Frauenfeld
    • Switzerland
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/07/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.