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    Clinical Trial Results:
    Effect of sevoflurane and propofol on hepato-splanchnic pressure and flow during hepatobiliary surgery.

    Summary
    EudraCT number
    		 2017-000071-90
    Trial protocol
    		 BE  
    Global end of trial date
    27 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2020
    First version publication date
    01 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2017/002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03772106
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    C. Heymanslaan 10, Ghent, Belgium,
    Public contact
    Bimetra Clinics, Ghent University Hospital, Bimetra.Clinics@uzgent.be
    Scientific contact
    Bimetra Clinics, Ghent University Hospital, 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
    10 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective of the study is to compare the effect of sevoflurane and propofol on hepato-splanchnic pressure and blood flow during hepatobiliary surgery. We hypothesized that sevoflurane induces a dose-dependent reduction of hepato-splanchnic blood flow, while propofol increases hepato-splanchnic blood flow.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jun 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: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 35 patients were screened in the period from 08-Jun-2017 till 27-Jan-2017. 29 patients were included, 27 patients were randomised. 18 patients were included and completed the trial. End of trial notification was dated 27-Jan-2018 (last patient last visit) and submitted to EC and CA 16-Nov-2108.

    Pre-assignment
    Screening details
    		 Inclusion Criteria - adult >+ 18 years (Female or Male) - ASA I-II-III -able to comprehend, sign and date the written consent document to participate in the clinical trial - sheduled for hepato-biliary surgery

    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 S
    Arm description
    		 Sevoflurane
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sevoflurane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Sevoflurane will be titrated according to BIS value between 45-55, which is an adequate depth of anesthesia for surgery

    Arm title
    		 group P
    Arm description
    		 propofol 1%
    Arm type
    		 Experimental

    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
    Propofol will be titrated according to a Bispectral Index (BIS) value between 45-55, which is an adequate depth of anesthesia for surgery

    Number of subjects in period 1
    		group S group P
    Started
    9
    9
    Completed
    9
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    group S
    Reporting group description
    		 Sevoflurane

    Reporting group title
    group P
    Reporting group description
    		 propofol 1%

    Reporting group values
    		 group S group P Total
    Number of subjects
    		 9 9 18
    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)
    		 4 4 8
        From 65-84 years
    		 5 5 10
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.9 ( 12 ) 63.6 ( 5.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 4 7
        Male
    		 6 5 11
    smoker
    Units: Subjects
        smoker
    		 5 1 6
        non-smoker
    		 4 8 12
    ASA (American Society of Anaestesiologist physical status)
    Units: Subjects
        ASA I
    		 0 1 1
        ASA II
    		 6 3 9
        ASA III
    		 3 5 8
    Somatostatin
    Patients received somatostatin at 250 g h-1 to reduce pancreatic secretion.
    Units: Subjects
        yes
    		 5 4 9
        no
    		 4 5 9
    BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 23.3 ( 2.5 ) 25.2 ( 2.5 ) -
    length
    Units: cm
        arithmetic mean (standard deviation)
    		 169.8 ( 7.9 ) 169.1 ( 8.8 ) -
    Systolic Blood Pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 125 ( 16 ) 133 ( 12 ) -
    Diastolic Blood Pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 76 ( 11 ) 78 ( 7 ) -
    Heart Rate
    Units: bpm
        arithmetic mean (standard deviation)
    		 73 ( 10 ) 72 ( 2 ) -
    weight
    Units: kg
        arithmetic mean (standard deviation)
    		 67.4 ( 9.9 ) 72.0 ( 7.5 ) -

    End points

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    End points reporting groups
    Reporting group title
    group S
    Reporting group description
    		 Sevoflurane

    Reporting group title
    group P
    Reporting group description
    		 propofol 1%

    Primary: Ratio PV/HA

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    End point title
    		 Ratio PV/HA [1]
    End point description
    End point type
    Primary
    End point timeframe
    Ratio PV/HA measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
    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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: ratio
    arithmetic mean (standard deviation)
        T1
    5.9 ( 5.8 )
    4.2 ( 2.8 )
        T2
    4.6 ( 4.1 )
    3.3 ( 1.6 )
        T3
    5.1 ( 5.5 )
    2.8 ( 1.1 )
    No statistical analyses for this end point

    Primary: P. Porta

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    End point title
    		 P. Porta [2]
    End point description
    End point type
    Primary
    End point timeframe
    P. Porta measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
    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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: mmHg
    arithmetic mean (standard deviation)
        T1
    8.7 ( 2.7 )
    10.1 ( 6.0 )
        T2
    9.9 ( 4.4 )
    6.0 ( 3.1 )
        T3
    8.6 ( 5.2 )
    8.3 ( 4.2 )
    No statistical analyses for this end point

    Primary: P. Cava

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    End point title
    		 P. Cava [3]
    End point description
    End point type
    Primary
    End point timeframe
    P. Cava measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
    Notes
    [3] - 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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: mmHg
    arithmetic mean (standard deviation)
        T1
    5.4 ( 3.2 )
    6.4 ( 2.9 )
        T2
    6.7 ( 3.9 )
    5.4 ( 2.6 )
        T3
    7.2 ( 2.6 )
    6.7 ( 4.4 )
    No statistical analyses for this end point

    Primary: Pulsatility Index (PI PV)

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    End point title
    		 Pulsatility Index (PI PV) [4]
    End point description
    End point type
    Primary
    End point timeframe
    PI PV measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
    Notes
    [4] - 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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: non-applicable
    arithmetic mean (standard deviation)
        T1
    0.5 ( 0.3 )
    0.4 ( 0.2 )
        T2
    0.5 ( 0.3 )
    0.3 ( 0.2 )
        T3
    0.5 ( 0.2 )
    0.5 ( 0.2 )
    No statistical analyses for this end point

    Primary: Pulsatility Index (PI HA)

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    End point title
    		 Pulsatility Index (PI HA) [5]
    End point description
    End point type
    Primary
    End point timeframe
    PI HA measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
    Notes
    [5] - 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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: non-aplicable
    arithmetic mean (standard deviation)
        T1
    1.7 ( 0.9 )
    1.4 ( 0.9 )
        T2
    1.5 ( 0.7 )
    1.4 ( 0.6 )
        T3
    1.5 ( 0.5 )
    1.4 ( 0.7 )
    No statistical analyses for this end point

    Primary: total HBF

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    End point title
    		 total HBF [6]
    End point description
    End point type
    Primary
    End point timeframe
    Total HBF measured at baseline (T1), post-resection (T2) and pre-reconstruction (T3)
    Notes
    [6] - 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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: ml/min
    arithmetic mean (standard deviation)
        t1
    1003 ( 411 )
    997 ( 344 )
        T2
    860 ( 318 )
    937 ( 231 )
        T3
    943 ( 225 )
    998 ( 264 )
    No statistical analyses for this end point

    Primary: PVF

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    End point title
    		 PVF [7]
    End point description
    End point type
    Primary
    End point timeframe
    PVF measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
    Notes
    [7] - 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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: ml/min
    arithmetic mean (standard deviation)
        T1
    790 ( 317 )
    760 ( 275 )
        T2
    612 ( 218 )
    687 ( 203 )
        T3
    704 ( 137 )
    714 ( 210 )
    No statistical analyses for this end point

    Primary: HAF

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    End point title
    		 HAF [8]
    End point description
    End point type
    Primary
    End point timeframe
    HAF measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
    Notes
    [8] - 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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: ml/min
    arithmetic mean (standard deviation)
        T1
    212 ( 138 )
    237 ( 150 )
        T2
    247 ( 199 )
    249 ( 110 )
        T3
    239 ( 149 )
    284 ( 101 )
    No statistical analyses for this end point

    Primary: Rel. HAF

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    End point title
    		 Rel. HAF [9]
    End point description
    End point type
    Primary
    End point timeframe
    Rel. HAF measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
    Notes
    [9] - 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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: percentage
    arithmetic mean (standard deviation)
        T1
    4.1 ( 3.4 )
    4.8 ( 2.8 )
        T2
    4.4 ( 3.7 )
    4.6 ( 1.9 )
        T3
    4.6 ( 3.5 )
    5.3 ( 2.0 )
    No statistical analyses for this end point

    Primary: Rel. PVF

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    End point title
    		 Rel. PVF [10]
    End point description
    End point type
    Primary
    End point timeframe
    Rel. PVF measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
    Notes
    [10] - 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: no statistical analysis available
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: percentage
    arithmetic mean (standard deviation)
        T1
    15.9 ( 9.4 )
    15.2 ( 5.2 )
        T2
    11.1 ( 5.3 )
    12.8 ( 3.7 )
        T3
    12.8 ( 3.8 )
    13.1 ( 3.8 )
    No statistical analyses for this end point

    Secondary: Mean Arterial Pressure (MAP)

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    End point title
    		 Mean Arterial Pressure (MAP)
    End point description
    End point type
    Secondary
    End point timeframe
    MAP measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: mmHg
    arithmetic mean (standard deviation)
        T0
    80 ( 11.3 )
    80 ( 8.7 )
        T1
    69 ( 10.2 )
    82 ( 9.5 )
        T2
    74 ( 8.6 )
    76 ( 5.3 )
        T3
    76 ( 8.6 )
    82 ( 4.5 )
        T4
    70 ( 7.6 )
    75 ( 5.4 )
    No statistical analyses for this end point

    Secondary: Heart Rate (HR)

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    End point title
    		 Heart Rate (HR)
    End point description
    End point type
    Secondary
    End point timeframe
    HR measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: bpm
    arithmetic mean (standard deviation)
        T0
    60 ( 9.1 )
    60 ( 9.6 )
        T1
    78 ( 14.0 )
    75 ( 12.5 )
        T2
    80 ( 10.9 )
    79 ( 9.9 )
        T3
    79 ( 12.3 )
    77 ( 8.3 )
        T4
    79 ( 10.1 )
    76 ( 9.8 )
    No statistical analyses for this end point

    Secondary: Central Venous Pressure (CVP)

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    End point title
    		 Central Venous Pressure (CVP)
    End point description
    End point type
    Secondary
    End point timeframe
    CVP measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: mmHg
    arithmetic mean (standard deviation)
        T0
    10 ( 3 )
    7 ( 2 )
        T1
    5 ( 2 )
    5 ( 2 )
        T2
    5 ( 4 )
    5 ( 1 )
        T3
    6 ( 2 )
    4 ( 2 )
        T4
    6 ( 1 )
    5 ( 2 )
    No statistical analyses for this end point

    Secondary: Cardiac Index (CI)

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    End point title
    		 Cardiac Index (CI)
    End point description
    End point type
    Secondary
    End point timeframe
    CI measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: l/(min.m²)
    arithmetic mean (standard deviation)
        T0
    2.6 ( 0.5 )
    2.5 ( 0.3 )
        T1
    3.1 ( 0.8 )
    2.7 ( 0.4 )
        T2
    3.3 ( 0.6 )
    3.0 ( 0.5 )
        T3
    3.2 ( 0.6 )
    3.0 ( 0.4 )
        T4
    3.3 ( 0.9 )
    3.0 ( 0.4 )
    No statistical analyses for this end point

    Secondary: Pulse Pressure Variation (PPV)

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    End point title
    		 Pulse Pressure Variation (PPV)
    End point description
    End point type
    Secondary
    End point timeframe
    PPV measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: percentage
    arithmetic mean (standard deviation)
        T0
    5 ( 2.9 )
    6 ( 2.3 )
        T1
    8 ( 4.6 )
    9 ( 4.0 )
        T2
    10 ( 5.6 )
    9 ( 1.7 )
        T3
    8 ( 5.8 )
    8 ( 3.0 )
        T4
    8 ( 5.2 )
    7 ( 2.1 )
    No statistical analyses for this end point

    Secondary: lactate

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    End point title
    		 lactate
    End point description
    End point type
    Secondary
    End point timeframe
    lactate measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: mg/dL
    arithmetic mean (standard deviation)
        T0
    9.7 ( 1.8 )
    8.7 ( 1.7 )
        T1
    12.2 ( 3.8 )
    8.9 ( 1.5 )
        T2
    16.3 ( 6.8 )
    10.1 ( 2.7 )
        T3
    18.2 ( 8.4 )
    10.5 ( 2.9 )
        T4
    22.4 ( 8.4 )
    12.5 ( 5.3 )
    No statistical analyses for this end point

    Secondary: PaCO2

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    End point title
    		 PaCO2
    End point description
    End point type
    Secondary
    End point timeframe
    PaCO2 measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: mmHg
    arithmetic mean (standard deviation)
        T0
    41 ( 6.5 )
    40 ( 5.7 )
        T1
    42 ( 5.9 )
    42 ( 4.5 )
        T2
    43 ( 4.8 )
    41 ( 6.1 )
        T3
    42 ( 5.1 )
    42 ( 3.3 )
        T4
    40 ( 3.0 )
    40 ( 2.0 )
    No statistical analyses for this end point

    Secondary: pH

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    End point title
    		 pH
    End point description
    End point type
    Secondary
    End point timeframe
    pH measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: non applicable
    arithmetic mean (standard deviation)
        T0
    7.35 ( 0.07 )
    7.38 ( 0.05 )
        T1
    7.34 ( 0.05 )
    7.36 ( 0.05 )
        T2
    7.33 ( 0.05 )
    7.35 ( 0.05 )
        T3
    7.35 ( 0.06 )
    7.34 ( 0.04 )
        T4
    7.35 ( 0.06 )
    7.36 ( 0.02 )
    No statistical analyses for this end point

    Secondary: amount of bloodloss

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    End point title
    		 amount of bloodloss
    End point description
    End point type
    Secondary
    End point timeframe
    from start of surgery until end of surgery
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: ml
        arithmetic mean (standard deviation)
    689 ( 448 )
    567 ( 212 )
    No statistical analyses for this end point

    Secondary: amount of colloids given during surgery

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    End point title
    		 amount of colloids given during surgery
    End point description
    End point type
    Secondary
    End point timeframe
    from start of surgery until end of surgery
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: ml
        arithmetic mean (standard deviation)
    1078 ( 441 )
    1067 ( 500 )
    No statistical analyses for this end point

    Secondary: need of ephedrine

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    End point title
    		 need of ephedrine
    End point description
    End point type
    Secondary
    End point timeframe
    from start of anesthesia until end of anesthesia
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: mg
        arithmetic mean (standard deviation)
    10.3 ( 5.6 )
    5.3 ( 3.3 )
    No statistical analyses for this end point

    Secondary: need of phenylephrine

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    End point title
    		 need of phenylephrine
    End point description
    End point type
    Secondary
    End point timeframe
    from start anesthesia until end of anesthesia
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: mg
        arithmetic mean (standard deviation)
    0.37 ( 0.4 )
    0.16 ( 0.1 )
    No statistical analyses for this end point

    Secondary: need of noradrenaline

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    End point title
    		 need of noradrenaline
    End point description
    End point type
    Secondary
    End point timeframe
    from start of anesthesia until end of anesthesia
    End point values
    		 group S group P
    Number of subjects analysed
    9
    9
    Units: ml
        arithmetic mean (standard deviation)
    46.8 ( 36.6 )
    3.8 ( 3.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    group S
    Reporting group description
    		 -

    Reporting group title
    group P
    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 non-serious adverse events were recorded for the participating patients
    Serious adverse events
    		 group S group P
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Hepatobiliary disorders
    Biliary anastomosis complication
    Additional description: Bile duct leakage after surgery
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 group S group P
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)

    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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