Trial document




drksid header

  DRKS00000663

Trial Description

start of 1:1-Block title

Title

Investigation of nociceptive and antinociceptive
mechanisms under anesthesia using fMRI, EEG and noxious reflexes

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

Trial Acronym

fMRT-Nociception

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

Even though the conscious experience of pain is not possible unter general anesthesia, painful stimuli can trigger harmful bodily responses. In this study we investigate the influence of the anesthetics propofol and remifentanil on the processing of painful stimuli during general anesthesia.

Therefore in this study healthy participants receive a general anesthesia using propofol and remifentanil. During the anesthesia the participants receive painful stimuli at different intensities and the reactions triggered by these stimuli are investigated using reflexes, measurements of the electrical brain activity (EEG) and measurements of the brain activity using nuclear magnetic resonance imaging (fMRI).

The aim of the study is to demonstrate that the anesthetics propofol and remifentanil influence the processing of pain under general anesthesia over different mechanisms.

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

Brief Summary in Scientific Language

It is intended to investigate the physiological mechanisms of the pocessing of nociception unter anesthesia induced with propofol and remifentanil in healthy volunteers by using the electrophsiological methods fMRI, EEG and noxious reflexes.

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

Organizational Data

  •   DRKS00000663
  •   2012/12/17
  •   [---]*
  •   yes
  •   Approved
  •   ZS EK 14 005 / 10, Ethik-Kommission des Landes Berlin
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2009-016907-41 
  •   4038410 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Nociception under anesthesia in healthy participants
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Healthy volunteers which receive an anesthesia using propofol and remifentanil and are investigated using EEG, fMRI and nociceptive reflexes
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

A dose-dependent reduction of BOLD-responses in pain-activated areas of the brain up to a complete cessation of signals by using propofol and remifentanil, imaged using functional magnetic resonance imaging

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

Secondary Outcome

Investigation whether clinical surrogate parameters for analgesia like movement on painful stimuli, heart rate, blood pressure, sweating, tearing, or parameters like EEG-parameters or nociceptive reflexes correlate with the suppression on pain-activated areas of the brain, imaged using magnetic resonance imaging

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

Countries of Recruitment

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

Locations of Recruitment

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

Recruitment

  •   Actual
  •   2013/04/20
  •   12
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

informed consent; age 18-60; no enrollment in other studies under the AMG (German medicinal products law)

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

Exclusion Criteria

any light or severe illness, especially even at the lightest stage: infections of the respiatory system, muscular diseases, diseases of the cns, chronical pain diseases, drug abuse, medication abuse; claustrophobia; increased risk of aspiration, especially adipositas (BMI > 30 kg/m2); pregnancy and lactation; history or family history of malign hyperthermia; history of family history of severe allergic reactions to propofol, remifentanil, soja, latex; placement in an institution on official order; implants, especially: pace makers, implanted cardioverters, cochlea implants, insulin pumps, nerve stimulators, vascular clips, cava filters, metal splints, screws, wires, plates; extensive or looped tattoos, unremovable piercings, other ferro-magnetic body onaments; unwillingness to comply to the filing and transmission of pseudonymous data about diseases in the scope of the clinical trial; actual of expected future dependence of the study personnell

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    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
    • Charité - Universitätsmedizin Berlin
    • Mr.  Dr.  Falk   von Dincklage 
    • Charitéplatz 1
    • 10117   Berlin
    • Germany
    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
    • Charité - Universitätsmedizin Berlin
    • Mr.  Dr.  Falk   von Dincklage 
    • Charitéplatz 1
    • 10117   Berlin
    • Germany
    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
    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
    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
  •   2013/08/19
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.