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    Clinical Trial Results:
    Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators

    Summary
    EudraCT number
    2014-000868-17
    Trial protocol
    ES  
    Global end of trial date
    18 Dec 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Nov 2021
    First version publication date
    24 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DEXPROPAR
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02256319
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Clinica Universidad de Navarra
    Sponsor organisation address
    AVENIDA PÍO XII, Nº 36, PAMPLONA/IRUÑA, Spain, 31008
    Public contact
    UCICEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    Scientific contact
    UCICEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    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
    16 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Study whether there are changes (and their characteristics) in local field potentials recordings in deep subcortical structures, obtained through the stimulators implanted to treat Parkinson's disease, with the administration of dexmedetomidine and propofol.
    Protection of trial subjects
    NA
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Oct 2014
    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
    Spain: 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)
    8
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    12 patiens, 18 Years and older.

    Pre-assignment
    Screening details
    This clinical trial has been designed to study and compare changes in deep brain activity (field potentials) in Parkinson's disease (PD) patients while awake, and during sedation with dexmedetomidine or propofol.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Treatment
    Arm description
    Experimental: Dexmedetomidine recording Recording registered through the deep brain stimulation electrodes with dexmedetomidine at 0.2 μg/kg/h. Intervention: Drug: Dexmedetomidine Active Comparator: Propofol recording Recording registered through the deep brain stimulation electrodes with propofol at plasmatic levels of 0.5, 1, 1.5, 2, 2.5 μg/mL. Intervention: Drug: Propofol No Intervention: Basal recording Recording registered through the deep brain stimulation electrodes with no sedation .
    Arm type
    Experimental

    Investigational medicinal product name
    DEXMEDETOMIDINE
    Investigational medicinal product code
    Other name
    (S)-4-[1-(2,3-Dimethylphenyl)ethyl]-3H-imidazole
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive a loading dose of 1 µg/kg in 10 min before starting the surgery. The maintenance dose will be 0.2-1 µg/kg/h for a Ramsey Sedation Score of 3-4 during the surgery´s preparation. It will be reduced to 0.2 µg/kg/h 15 min before starting the microelectrode recording for a Ramsey Sedation Score of 2. After the placement of the deep brain stimulator we will record the local field potentials activity. In addition, the subscales of rigidity, tremor and bradykinesia of the Unified Parkinson's Disease Rating Scale (UPDRS-III) score will be evaluated. Once the deep brain stimulator recording and neurologic exploration will be over patients will receive a maintenance dose 0.2-1 µg/kg/h until the end of the surgery. It will be stopped to transfer the patient to the ICU.

    Investigational medicinal product name
    PROPOFOL-LIPURO
    Investigational medicinal product code
    Other name
    2,6-diisopropylphenol
    Pharmaceutical forms
    Emulsion for emulsion for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The target doses are 0.5, 1, 1.5, 2 and 2.5 µg/kg. For its administration we will use the TCI (target controlled infusion) system. After programming each dose we will wait until the plasma and brain concentration of propofol are stabilized in this target and then we will record the local field potentials activity through the DBS. In addition, the subscales of rigidity, tremor and bradykinesia of the UPDRS-III score will be evaluated.

    Number of subjects in period 1
    Treatment
    Started
    12
    Completed
    11
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    A total of 12 patients with PD were invited to participate in this study. The participation rate was 100%. One patient was excluded due to an intraoperative adverse event. This patient experienced pharyngeal dystonia and developed dyspnea before DBS implantation, leading to a change in the anesthesia from cooperative sedation to general anesthesia. We also excluded from the analyses the unique patient whose target nucleus was GPi.

    Reporting group values
    Treatment period 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)
    8 8
        From 65-84 years
    3 3
        85 years and over
    1 1
        Adults
    0 0
    Gender categorical
    Units: Subjects
        Female
    2 2
        Male
    10 10

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    Experimental: Dexmedetomidine recording Recording registered through the deep brain stimulation electrodes with dexmedetomidine at 0.2 μg/kg/h. Intervention: Drug: Dexmedetomidine Active Comparator: Propofol recording Recording registered through the deep brain stimulation electrodes with propofol at plasmatic levels of 0.5, 1, 1.5, 2, 2.5 μg/mL. Intervention: Drug: Propofol No Intervention: Basal recording Recording registered through the deep brain stimulation electrodes with no sedation .

    Primary: Changes in LFP recordings. Propofol

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    End point title
    Changes in LFP recordings. Propofol [1]
    End point description
    Study whether there are changes (and their characteristics) in local field potentials recordings in deep subcortical structures, obtained through the stimulators implanted to treat Parkinson's disease, with the administration of dexmedetomidine and propofol. Data are shown as the mean difference between baseline and prpofol LFP . There was a significant decline of 12.7% (95% CI, −21.3 to −4.7) in the relative beta power of the local field potentials for each increment in the estimated peak propofol concentrations at the effect site relative to the control recordings.
    End point type
    Primary
    End point timeframe
    Propofol was administered (about 2 hours) one day after the stimulator reading (baseline).
    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: A significant 12.7% (95% CI, 4.1 to 21.3) decline in the LFPs relative to the control recordings was evident for eachincrement in the estimated peak effect site concentration of propofol (0.5, 1.0, 1.5, 2.0, and 2.5 μg/ml) when all nuclei were analyzed.
    End point values
    Treatment
    Number of subjects analysed
    9
    Units: p value
    number (not applicable)
        p value
    0.004
    No statistical analyses for this end point

    Primary: Changes in LFP recordings. Dexmedetomidine

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    End point title
    Changes in LFP recordings. Dexmedetomidine [2]
    End point description
    End point type
    Primary
    End point timeframe
    Dexmedetomidine was administered (for about 6 hours), 3-4 days before the stimulator readind.
    Notes
    [2] - 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: Dexmedetomidine administration at 0.2 μg∙kg-1∙h-1 caused minimal changes in the power distribution. Accordingly, no significant difference was observed when comparing the relative beta power of LFPs (RBP-LFPs) between dexmedetomidine and control recordings, with a mean difference in the RBP-LFPs between dexmedetomidine and control recordings of −7.7 (95% CI, −18.9 to 3.8) when all nuclei were analyzed.
    End point values
    Treatment
    Number of subjects analysed
    12
    Units: p value
        number (not applicable)
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In the event that an SAE occurs, it must be notified within 24 hours after having knowledge of the event. Any SAE that occur after the completion of the trial should be reported if the investigator believes the SAE is related to the study treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    ND
    Dictionary version
    ND
    Reporting groups
    Reporting group title
    Experimental group
    Reporting group description
    -

    Serious adverse events
    Experimental group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Pharyngeal dyskinesias
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Experimental group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    Vascular disorders
    Brain pressure without headache
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hematoma
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Surgical and medical procedures
    Surgical wound pain
         subjects affected / exposed
    6 / 12 (50.00%)
         occurrences all number
    6
    Immune system disorders
    Sickness
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    5
    Tremor in ESI
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Drowsiness
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Motor block sensation
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    5
    Dizziness
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Vasovagal reaction
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    5
    Loss of appetite
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Apathy
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    Anxiety disorder
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Shoulder pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gout
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    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
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