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    Clinical Trial Results:
    Offline monitoring of parallel concentrations of intravenously administered anesthetics, opiates and relaxants in breath and in blood during anesthesia - a pilot study

    Summary
    EudraCT number
    		 2013-004127-36
    Trial protocol
    		 CZ  
    Global end of trial date
    30 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Aug 2020
    First version publication date
    12 Aug 2020
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    expir1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Podřipská nemocnice s poliklinikou
    Sponsor organisation address
    Alej 17. listopadu 1101, Roudnice n.L., s.r.o, Czech Republic,
    Public contact
    Michal Kroupa, Podřipská nemocnice s poliklinikou, Roudnice n.L., s.r.o, mudrmichalkroupa@seznam.cz
    Scientific contact
    Michal Kroupa, Podřipská nemocnice s poliklinikou, Roudnice n.L., s.r.o, mudrmichalkroupa@seznam.cz
    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
    30 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    pharmacokinetics
    Protection of trial subjects
    Standard
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Feb 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
    Czech Republic: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 22
    Number of subjects completed
    		 22

    Period 1
    Period 1 title
    Main period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Main arm
    Arm description
    		 All drugs used and monitored in the study were administered SKH during general anesthesia at the planned procedure. Thus, it was administered independently of the study, in a standard manner common to general anesthesia and according to SPC. Due to the clinical study, the indication and dosage during anesthesia were not altered. Therefore, in this pilot study, which aims to determine the relationship of concentration at certain (below) time intervals, no detailed characteristics and dosages of the substances were given. These are listed in the anesthesiology textbooks and in the SPC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection, Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    inj. and 5 µg of sufentanil or 50 µg of sufentanil

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection, Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amp. á 200mg, bottle. 500mg or 1000mg. Propofol

    Investigational medicinal product name
    Ultiva
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection, Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    inj. á 1mg, or 2mg, or Remifentanil á 1mg, 2mg, or 5mg remifentanil

    Investigational medicinal product name
    Rocuronium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection, Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    inj. 50mg rocuronium

    Number of subjects in period 1
    		Main arm
    Started
    22
    Completed
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main period
    Reporting group description
    		 -

    Reporting group values
    		 Main period Total
    Number of subjects
    		 22 22
    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)
    		 0 0
        From 65-84 years
    		 22 22
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 3 3
    Subject analysis sets

    Subject analysis set title
    Population selection
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The study included SKH with ASA 1-2 aged 18-65 years, undergoing a planned operation of at least 30 min, where the use of any of these substances was expected. As this was a pilot study with the assumption of limited choice of SKH (small hospital with limited surgery), no other selection criterion was chosen, nor was there an effort for gender parity (a large part of SKH was anesthetized for gynecological performance and therefore in the study was the prevalence of women). A prerequisite for this was the consent of SKH to conduct the study.

    Subject analysis sets values
    		 Population selection
    Number of subjects
    22
    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)
    0
        From 65-84 years
    22
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    19
        Male
    3

    End points

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    End points reporting groups
    Reporting group title
    Main arm
    Reporting group description
    		 All drugs used and monitored in the study were administered SKH during general anesthesia at the planned procedure. Thus, it was administered independently of the study, in a standard manner common to general anesthesia and according to SPC. Due to the clinical study, the indication and dosage during anesthesia were not altered. Therefore, in this pilot study, which aims to determine the relationship of concentration at certain (below) time intervals, no detailed characteristics and dosages of the substances were given. These are listed in the anesthesiology textbooks and in the SPC.

    Subject analysis set title
    Population selection
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The study included SKH with ASA 1-2 aged 18-65 years, undergoing a planned operation of at least 30 min, where the use of any of these substances was expected. As this was a pilot study with the assumption of limited choice of SKH (small hospital with limited surgery), no other selection criterion was chosen, nor was there an effort for gender parity (a large part of SKH was anesthetized for gynecological performance and therefore in the study was the prevalence of women). A prerequisite for this was the consent of SKH to conduct the study.

    Primary: Main end point

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    End point title
    		 Main end point [1]
    End point description
    End point type
    Primary
    End point timeframe
    150 min
    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: There was no comparison conducted, only one data set
    End point values
    		 Main arm
    Number of subjects analysed
    22
    Units: concentration mug/l
        number (not applicable)
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    None
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 1%
    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: There were no experimental drugs administrated, only standard anesthetics. Their concentration in breath was observed.

    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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    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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