Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Investigation of nociceptive and antinociceptive mechanisms under anesthesia using fMRI, EEG and noxious reflexes

    Summary
    EudraCT number
    		 2009-016907-41
    Trial protocol
    		 DE  
    Global end of trial date
    19 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions
    Summary report(s)
    		 Summary

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    fMRT-Nociception
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Falk von Dincklage, Charité - Universitätsmedizin Berlin, +49 030450531227, falk.von-dincklage@charite.de
    Scientific contact
    Falk von Dincklage, Charité - Universitätsmedizin Berlin, +49 030450531227, falk.von-dincklage@charite.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of anaesthestics on the cerebral and spinal responsiveness to noxious stimulation
    Protection of trial subjects
    General anesthesia was conducted according to clinical standards and appropriate guidelines. Protection by anesthetic standard monitoring and two anesthesiologists present of which at least one is a fully certified anesthesiology specialist.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects recruited via advertising at Charité - Universitätsmedizin Berlin

    Pre-assignment
    Screening details
    		 Screening was conducted by performing an awake measurement in der MRI-scanner to test whether the subjects were comfortable to stay there for at least 30mins and hold still to perform the measurements.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding in this study as it is an exploratory study.

    Arms
    Arm title
    		 Main
    Arm description
    		 All subjects in this arm
    Arm type
    		 All subjects of the trial

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administration of Propofol as in clinical practice for general anesthesia according to hospital standards and appropriate guidelines (iv infusion at 0-10 µg/ml effect-side-concentrations)

    Investigational medicinal product name
    Remifentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administration of Remifentanil as in clinical practice for general anesthesia according to hospital standards and appropriate guidelines (iv infusion at 0-8 ng/ml effect-side-concentrations)

    Number of subjects in period 1
    		Main
    Started
    12
    Completed
    12

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 6 6
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Analysis of all subjects of which the recorded data could be analyzed.

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    10
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    10
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    5
        Male
    5

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Main
    Reporting group description
    		 All subjects in this arm

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Analysis of all subjects of which the recorded data could be analyzed.

    Primary: Cerebral response evoked by nociceptive stimulus during deep anaesthesia

    		 Close Top of page
    End point title
    		 Cerebral response evoked by nociceptive stimulus during deep anaesthesia
    End point description
    End point type
    Primary
    End point timeframe
    During deep anaesthesia of 10 µg/ml effect-site concentration of propofol
    End point values
    		 Main Full analysis
    Number of subjects analysed
    10
    10
    Units: microvolt*s
        arithmetic mean (standard error)
    0.905 ± 0.173
    0.905 ± 0.173
    Statistical analysis title
    		 Cerebral effect nociceptive vs innocuous stimulus
    Statistical analysis description
    Statistical comparison whether the nociceptive stimulus evokes a cerebral response that differs from that evoked by the innocuous stimulus.
    Comparison groups
    Main v Full analysis
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - Exploratory analysis to investigate the effect of anesthetics on nociception

    Secondary: Cerebral response evoked by innocuous stimulus during deep anaesthesia

    		 Close Top of page
    End point title
    		 Cerebral response evoked by innocuous stimulus during deep anaesthesia
    End point description
    End point type
    Secondary
    End point timeframe
    During deep anaesthesia of 10 µg/ml effect-site concentration of propofol
    End point values
    		 Main Full analysis
    Number of subjects analysed
    10
    10
    Units: microvolt*s
        arithmetic mean (standard error)
    0.141 ± 0.052
    0.141 ± 0.052
    Statistical analysis title
    		 Cerebral effect nociceptive vs innocuous stimulus
    Statistical analysis description
    Statistical comparison whether the nociceptive stimulus evokes a cerebral response that differs from that evoked by the innocuous stimulus.
    Comparison groups
    Main v Full analysis
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [2] - Exploratory analysis to investigate the effect of anesthetics on nociception

    Secondary: Spinal response evoked by nociceptive stimulus during deep anaesthesia

    		 Close Top of page
    End point title
    		 Spinal response evoked by nociceptive stimulus during deep anaesthesia
    End point description
    End point type
    Secondary
    End point timeframe
    During deep anaesthesia of 10 µg/ml effect-site concentration of propofol
    End point values
    		 Main Full analysis
    Number of subjects analysed
    10
    10
    Units: microvolt*s
        arithmetic mean (standard error)
    2.367 ± 0.505
    2.367 ± 0.505
    Statistical analysis title
    		 Spinal effect nociceptive vs innocuous stimulus
    Statistical analysis description
    Statistical comparison whether the nociceptive stimulus evokes a spinal response that differs from that evoked by the innocuous stimulus.
    Comparison groups
    Main v Full analysis
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [3] - Exploratory analysis to investigate the effect of anesthetics on nociception

    Secondary: Spinal response evoked by innocuous stimulus during deep anaesthesia

    		 Close Top of page
    End point title
    		 Spinal response evoked by innocuous stimulus during deep anaesthesia
    End point description
    End point type
    Secondary
    End point timeframe
    During deep anaesthesia of 10 µg/ml effect-site concentration of propofol
    End point values
    		 Main Full analysis
    Number of subjects analysed
    10
    10
    Units: microvolt*s
        arithmetic mean (standard error)
    0.024 ± 0.007
    0.024 ± 0.007
    Statistical analysis title
    		 Spinal effect nociceptive vs innocuous stimulus
    Comparison groups
    Main v Full analysis
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [4] - Statistical comparison whether the nociceptive stimulus evokes a spinal response that differs from that evoked by the innocuous stimulus.

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Complete trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2021-07-31
    Reporting groups
    Reporting group title
    All trial participants
    Reporting group description
    		 All 12 subjects investigated in the trial

    Serious adverse events
    		 All trial participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All trial participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: As this exploratory study was conductued in only 12 healthy subjects and all medication was used only within normal clinical ranges, this trial did not have adverse events.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29935584
    http://www.ncbi.nlm.nih.gov/pubmed/29421324
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 12:42:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA