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    Clinical Trial Results:
    Dexmedetomidine versus propofol in awake implantation of a neuromodulative system.

    Summary
    EudraCT number
    		 2015-000964-33
    Trial protocol
    		 NL  
    Global end of trial date
    20 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jan 2020
    First version publication date
    28 Jan 2020
    Other versions
    Summary report(s)
    		 DexMedPro RCT

    Trial information

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    Trial identification
    Sponsor protocol code
    Feline02
    Additional study identifiers
    ISRCTN number
    		 ISRCTN46302353
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Erasmus Medical Center
    Sponsor organisation address
    Doctor Molewaterplein 40, Rotterdam, Netherlands, 3015 GD Rotterdam
    Public contact
    Prof. Dr. F.J.P.M. Huygen, Erasmus Medical Center, Department of Anesthesiology, f.huygen@erasmusmc.nl
    Scientific contact
    Prof. Dr. F.J.P.M. Huygen, Erasmus Medical Center, Department of Anesthesiology, f.huygen@erasmusmc.nl
    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
    01 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Patient satisfaction
    Protection of trial subjects
    Hemodynamic and respiratory measurements Pain measurements
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2015
    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
    Netherlands: 72
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    72
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 See inclusion criteria

    Pre-assignment
    Screening details
    		 See inclusion criteria: - Age 18-65 years - Indication for a neurostimulator - No exclusion criteria applicable

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Sedation was performed by an anesthesiologist who could not be blinded to the study group allocation because the sedation protocols for dexmedetomidine and propofol are different. The patient and the operator however were blinded to the study group allocation. In addition, a blinded observer, not involved in the sedation or the interventional procedure, enrolled the patients and performed all perioperative study measurements.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dexmedetomidine group
    Arm description
    		 Dexmedetomidine infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexmedetomidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients in the dexmedetomidine group received a loading dose of dexmedetomidine of 1 μg/kg over 10 minutes to achieve the required level of sedation, followed by a maintenance dose of 0.6 μg/kg/h.

    Arm title
    		 Propofol
    Arm description
    		 Propofol infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects in the propofol group received a loading infusion of 0.5 mg/kg propofol 1% over 10 minutes followed by a maintenance dose of 2.0 mg/kg/h.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: The trial was considered single blinded because the anesthesiologist who administered the sedative agents was not blinded. Furthermore the patient, investigator, collector and operator were blinded. This is further reported in the publication.
    Number of subjects in period 1
    		Dexmedetomidine group Propofol
    Started
    36
    36
    Completed
    36
    36

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dexmedetomidine group
    Reporting group description
    		 Dexmedetomidine infusion

    Reporting group title
    Propofol
    Reporting group description
    		 Propofol infusion

    Reporting group values
    		 Dexmedetomidine group Propofol Total
    Number of subjects
    		 36 36 72
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 36 36 72
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 24 27 51
        Male
    		 12 9 21
    Subject analysis sets

    Subject analysis set title
    Dexmedetomidine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Dexmedetomidine infusion

    Subject analysis set title
    Propofol
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Propofol infusion

    Subject analysis sets values
    		 Dexmedetomidine Propofol
    Number of subjects
    35
    34
    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)
    35
    34
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    23
    25
        Male
    12
    9

    End points

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    End points reporting groups
    Reporting group title
    Dexmedetomidine group
    Reporting group description
    		 Dexmedetomidine infusion

    Reporting group title
    Propofol
    Reporting group description
    		 Propofol infusion

    Subject analysis set title
    Dexmedetomidine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Dexmedetomidine infusion

    Subject analysis set title
    Propofol
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Propofol infusion

    Primary: Patient satisfaction

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    End point title
    		 Patient satisfaction [1]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See trial publication for complete statistical analysis
    End point values
    Number of subjects analysed
    Units: 20
        number (not applicable)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During study period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 not applicable
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Dexmedetomidine group
    Reporting group description
    		 One patient in the dexmedetomidine group was affected by a SAE

    Reporting group title
    Propofol group
    Reporting group description
    		 -

    Serious adverse events
    		 Dexmedetomidine group Propofol group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    vasovagal collaps
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 Dexmedetomidine group Propofol group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 35 (17.14%)
    9 / 34 (26.47%)
    Cardiac disorders
    Hypotension
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    Bradycardia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Desaturation
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 34 (11.76%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Unwanted movement
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1

    More information

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    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/31321763
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    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.

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