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    Clinical Trial Results:
    Influence of a bolus administration of ephedrine and phenylephrine on spinal oxygen saturation, measured with NIRS.

    Summary
    EudraCT number
    		 2016-001839-13
    Trial protocol
    		 BE  
    Global end of trial date
    09 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2020
    First version publication date
    15 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2016/006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03767296
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium,
    Public contact
    Bimetra Clinics, Ghent University Hospital, +32 93320500, bimetra.clinics@uzgent.be
    Scientific contact
    Bimetra Clinics, Ghent University Hospital, +32 93320500, bimetra.clinics@uzgent.be
    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
    07 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the effect of vasoactive agents (ephedrine and phenylephrine) on the spinal vasculature by measuring spinal oxygenation, using near infrared spectroscopy in peripheral vascular surgery.
    Protection of trial subjects
    Ethics review and approval, informed consent and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Feb 2017
    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
    Belgium: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    11
    From 65 to 84 years
    15
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 33 patients were included in the period 06-Feb-2017 until 09-Sep-2017. 5 drop-outs been replaced. End of trial notification was dated 09-Sep-2017 (last patient last visit) and submitted to EC and CA 06-Dec-2018.

    Pre-assignment
    Screening details
    		 Patients who are 18 years or older and who are scheduled for dilatation of arterial bloos vessels of the lower limb. Patients were screened as per inclusion and exclusion criteria per protocol.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Ephedrine- Phenylephrine - Ephedrine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ephedrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease > 20%: 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) (until x mg) A total amount of 140 mg Ephedrine will not be exceeded.

    Investigational medicinal product name
    Phenylephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease >20%: 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) A total amount of 1500 μg will not be exceeded.

    Investigational medicinal product name
    Ephedrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Decrease MAP > 20%: 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) (starting from x mg) A total amount of 140 mg Ephedrine will not be exceeded.

    Arm title
    		 Group 2
    Arm description
    		 Phenylephrine- Ephedrine - Phenylephrine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Phenylephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease > 20%: 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) (until x mg) A total amount of 1500 μg will not be exceeded.

    Investigational medicinal product name
    Ephedrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Decrease MAP > 20%: 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) (starting from x mg) A total amount of 140 mg Ephedrine will not be exceeded.

    Investigational medicinal product name
    Phenylephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease > 20%: 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) (starting from x mg) A total amount of 1500 μg will not be exceeded.

    Arm title
    		 Group 3
    Arm description
    		 Ephedrine- Ephedrine - Ephedrine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ephedrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease > 20%: 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) (until x mg) A total amount of 140 mg Ephedrine will not be exceeded.

    Investigational medicinal product name
    Ephedrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease > 20%: 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) (from x mg until y mg) A total amount of 140 mg Ephedrine will not be exceeded.

    Investigational medicinal product name
    Ephedrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease > 20%: 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) (from y mg) A total amount of 140 mg Ephedrine will not be exceeded.

    Arm title
    		 Group 4
    Arm description
    		 Phenylephrine- Phenylephrine - Phenylephrine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Phenylephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease >20%: 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) (until x mg) A total amount of 1500 μg will not be exceeded.

    Investigational medicinal product name
    Phenylephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease >20%: 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) (starting from x until y mg) A total amount of 1500 μg will not be exceeded.

    Investigational medicinal product name
    Phenylephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    MAP decrease >20%: 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) (starting from y mg) A total amount of 1500 μg will not be exceeded.

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4
    Started
    7
    7
    7
    7
    Completed
    7
    7
    7
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Ephedrine- Phenylephrine - Ephedrine

    Reporting group title
    Group 2
    Reporting group description
    		 Phenylephrine- Ephedrine - Phenylephrine

    Reporting group title
    Group 3
    Reporting group description
    		 Ephedrine- Ephedrine - Ephedrine

    Reporting group title
    Group 4
    Reporting group description
    		 Phenylephrine- Phenylephrine - Phenylephrine

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Total
    Number of subjects
    		 7 7 7 7 28
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    		 70 (56 to 81) 61 (48 to 84) 66 (54 to 83) 67 (52 to 87) -
    Gender categorical
    Units: Subjects
        Female
    		 3 1 6 4 14
        Male
    		 4 6 1 3 14
    BMI
    Units: kg/m²
        median (full range (min-max))
    		 23.5 (17.5 to 25.8) 27.4 (19.3 to 29.9) 27.6 (18.4 to 30.0) 24.6 (19.6 to 27.3) -

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Ephedrine- Phenylephrine - Ephedrine

    Reporting group title
    Group 2
    Reporting group description
    		 Phenylephrine- Ephedrine - Phenylephrine

    Reporting group title
    Group 3
    Reporting group description
    		 Ephedrine- Ephedrine - Ephedrine

    Reporting group title
    Group 4
    Reporting group description
    		 Phenylephrine- Phenylephrine - Phenylephrine

    Subject analysis set title
    Ephedrine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients treated with ephedrine for MAP decrease > 20%

    Subject analysis set title
    Phenylephedrine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients treated with phenylephedrine for MAP decrease > 20%

    Primary: Spinal oxygen saturation measured by NIRS (T3-T4)

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    End point title
    		 Spinal oxygen saturation measured by NIRS (T3-T4)
    End point description
    End point type
    Primary
    End point timeframe
    From start induction until end of procedure
    End point values
    		 Ephedrine Phenylephedrine
    Number of subjects analysed
    21
    21
    Units: percentage
    arithmetic mean (standard deviation)
        Pre
    78.4 ( 7.4 )
    79.5 ( 8.3 )
        Post
    77.1 ( 8.6 )
    79.9 ( 7.7 )
        Pre-Post difference
    -1.3 ( 3.4 )
    0.4 ( 2.5 )
    Statistical analysis title
    		 Analysis
    Comparison groups
    Ephedrine v Phenylephedrine
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 -1.1
    Variability estimate
    Standard deviation

    Primary: Spinal oxygen saturation measured by NIRS (T9-T10)

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    End point title
    		 Spinal oxygen saturation measured by NIRS (T9-T10)
    End point description
    End point type
    Primary
    End point timeframe
    From start induction until end of procedure
    End point values
    		 Ephedrine Phenylephedrine
    Number of subjects analysed
    21
    21
    Units: percentage
    arithmetic mean (standard deviation)
        Pre
    73.4 ( 10.9 )
    74.7 ( 8.9 )
        Post
    72.6 ( 11.4 )
    75.4 ( 8.8 )
        Pre-Post difference
    -0.7 ( 2.6 )
    0.7 ( 2.0 )
    Statistical analysis title
    		 Statystical analysis
    Comparison groups
    Phenylephedrine v Ephedrine
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.006
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 -0.4
    Variability estimate
    Standard deviation

    Primary: Spinal oxygen saturation measured by NIRS (L1-L2)

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    End point title
    		 Spinal oxygen saturation measured by NIRS (L1-L2)
    End point description
    End point type
    Primary
    End point timeframe
    From start induction until end of procedure
    End point values
    		 Ephedrine Phenylephedrine
    Number of subjects analysed
    21
    21
    Units: percentage
    arithmetic mean (standard deviation)
        Pre
    76.0 ( 11.8 )
    76.0 ( 10.5 )
        Post
    74.7 ( 12.3 )
    75.9 ( 10.2 )
        Pre-Post difference
    -1.3 ( 2.7 )
    -0.1 ( 1.4 )
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Ephedrine v Phenylephedrine
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 -0.8
    Variability estimate
    Standard deviation

    Secondary: Cerebral oxygenation (NIRS)

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    End point title
    		 Cerebral oxygenation (NIRS)
    End point description
    End point type
    Secondary
    End point timeframe
    From start induction until end procedure
    End point values
    		 Ephedrine Phenylephedrine
    Number of subjects analysed
    21
    21
    Units: percentage
    arithmetic mean (standard deviation)
        Pre
    65.3 ( 8.3 )
    66.4 ( 8.9 )
        Post
    64.7 ( 7.7 )
    63.7 ( 9.1 )
        Pre-post difference
    -0.6 ( 3.9 )
    -2.7 ( 3.5 )
    No statistical analyses for this end point

    Secondary: Heartrate

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    End point title
    		 Heartrate
    End point description
    End point type
    Secondary
    End point timeframe
    From start induction until end procedure
    End point values
    		 Ephedrine Phenylephedrine
    Number of subjects analysed
    21
    21
    Units: bpm
    arithmetic mean (standard deviation)
        Pre
    58 ( 11 )
    60 ( 12 )
        Post
    61 ( 11 )
    57 ( 12 )
        Pre-Post difference
    3 ( 6 )
    -3 ( 5 )
    No statistical analyses for this end point

    Secondary: Blood pressure

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    End point title
    		 Blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    From start induction until end procedure
    End point values
    		 Ephedrine Phenylephedrine
    Number of subjects analysed
    21
    21
    Units: mmHg
    arithmetic mean (standard deviation)
        Pre
    68 ( 10 )
    73 ( 11 )
        Post
    80 ( 12 )
    86 ( 12 )
        Pre-Post difference
    12 ( 9 )
    13 ( 8 )
    No statistical analyses for this end point

    Secondary: Total amount of vasoactive medication used

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    End point title
    		 Total amount of vasoactive medication used
    End point description
    End point type
    Secondary
    End point timeframe
    From start induction until end of procedure
    End point values
    		 Ephedrine Phenylephedrine
    Number of subjects analysed
    21
    21
    Units: µg
        median (full range (min-max))
    18000 (6000 to 144000)
    100 (50 to 500)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events will be reported between the first dose administration of trial medication and the last trial related activity.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Group 4
    Reporting group description
    		 -

    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: No other adverse events occurred during the study
    Serious adverse events
    		 Group 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Myocardial rupture
    Additional description: Pseudo aneurysme : surgical complication
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Oct 2016
    Protocol update to version 6

    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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