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    Clinical Trial Results:
    The reversed isolated forearm technique to regionally reverse rocuronium induced muscle relaxation – a pilot study

    Summary
    EudraCT number
    		 2013-002164-53
    Trial protocol
    		 AT  
    Global end of trial date
    24 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2020
    First version publication date
    27 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20130513
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria,
    Public contact
    Forschungsbüro, Fr. Mag. Vecs, Medizinische Universität Wien, Abteilung für Allgemeine Anästhesie und Intensivmedizin, +43 1404002031, eleonora.vecs@meduniwien.ac.at
    Scientific contact
    Forschungsbüro, Fr. Mag. Vecs, Medizinische Universität Wien, Abteilung für Allgemeine Anästhesie und Intensivmedizin, +43 1404002031, eleonora.vecs@meduniwien.ac.at
    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
    25 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the feasibility of regionally reversing a rocuronium induced muscle relaxation and to determine the dose of sugammadex that is necessary to reach a train of four (TOF) ratio ≥ 0.9.
    Protection of trial subjects
    Patients were closely observed intra- and postoperatively for any adverse reaction to the intervention.
    Background therapy
    		 Elective surgery with the need of general anaesthesia and muscle relaxation with rocuronium.
    Evidence for comparator
    		 No comparator
    Actual start date of recruitment
    09 Dec 2013
    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
    Austria: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients unterging an elective operation with the need of general anaesthesia with muscle relaxation were asked preoperatively if they want to participate in the study.

    Pre-assignment
    Screening details
    		 Patients unterging an elective operation with the need of general anaesthesia with muscle relaxation were screened for eligibility preoperatively

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    none

    Arms
    Arm title
    		 Baseline
    Arm description
    		 Patients before proceeding to period "Dose finding" or "Dose effect"
    Arm type
    		 no intervention

    Investigational medicinal product name
    none
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Other use
    Dosage and administration details
    no product was used at baseline

    Number of subjects in period 1
    		Baseline
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    Dose finding
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    none

    Arms
    Arm title
    		 Dose finding
    Arm description
    		 The dose-titration process was designed as follows. The ini- tial dose in the first patient was set to be sugammadex 0.5 mg kg−1 diluted in 30 ml normal saline. If the TOF ratio remained below 0.9 for the next 5 min, a top-up dose of one-quarter of this dose (e.g. sugammadex 0.125 mg kg−1 in Patient 1) diluted in 10 ml of 0.9% saline was administered. This procedure was re- peated until a stable TOF ratio ≥0.9 (three consecutive measure- ments ≥0.9) was reached in the interventional limb or until a total of four injections were given. If a TOF ratio ≥0.9 was achieved with this titration, the initial and top-up sugammadex doses in the next patient were reduced to one-quarter of the initial dose given to the previous patient but were still diluted in 30 ml saline (10 ml for top-up doses). For example, if the muscle paralysis of Patient 1 was antagonized after the initial dose of sugammadex 0.5 mg kg−1, the initial and the top-up doses would be reduced to 1.25 mg kg−1 in Patient 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sugammadex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose-titration process was designed as follows. The ini- tial dose in the first patient was set to be sugammadex 0.5 mg kg−1 diluted in 30 ml normal saline. If the TOF ratio remained below 0.9 for the next 5 min, a top-up dose of one-quarter of this dose (e.g. sugammadex 0.125 mg kg−1 in Patient 1) diluted in 10 ml of 0.9% saline was administered. This procedure was re- peated until a stable TOF ratio ≥0.9 (three consecutive measure- ments ≥0.9) was reached in the interventional limb or until a total of four injections were given. If a TOF ratio ≥0.9 was achieved with this titration, the initial and top-up sugammadex doses in the next patient were reduced to one-quarter of the initial dose given to the previous patient but were still diluted in 30 ml saline (10 ml for top-up doses). For example, if the muscle paralysis of Patient 1 was antagonized after the initial dose of sugammadex 0.5 mg kg−1, the initial and the top-up doses would be reduced to 1.25 mg kg−1 in Patient 2.

    Number of subjects in period 2 [1]
    		Dose finding
    Started
    10
    Completed
    10
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 20 Patients were included at baseline, 10 of these patients participated in study period "dose finding" and 10 of the patients participated in the period "time to effect". All patients completed the study
    Period 3
    Period 3 title
    Dose effect
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    none

    Arms
    Arm title
    		 Dose Effect
    Arm description
    		 In this group, dose titration was not performed, and all patients received the same amount of sugammadex diluted in the same volume (30 ml normal saline). The TOF was again measured every 15 s in both arms, and the effects of the sugammadex dose on muscle paralysis in both arms were recorded. The tour- niquet was released 15 min after sugammadex was injected, and the effect of this dose on the TOF values in both arms was re- corded until the TOF ratio returned to ≥0.9 in both arms.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sugammadex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    In this group, dose titration was not performed, and all patients received the same amount of sugammadex diluted in the same volume (30 ml normal saline). The TOF was again measured every 15 s in both arms, and the effects of the sugammadex dose on muscle paralysis in both arms were recorded. The tour- niquet was released 15 min after sugammadex was injected, and the effect of this dose on the TOF values in both arms was re- corded until the TOF ratio returned to ≥0.9 in both arms.

    Number of subjects in period 3
    		Dose Effect
    Started
    10
    Completed
    10

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 20 20
    Age categorical
    Baseline characteristics
    Units: Subjects
        Adults (18-64 years)
    		 20 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38 ± 12 -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 10 10
    Subject analysis sets

    Subject analysis set title
    Dose finding of sugammadex
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    descriptive

    Subject analysis set title
    Dose to effect
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    descriptive

    Subject analysis sets values
    		 Dose finding of sugammadex Dose to effect
    Number of subjects
    10
    10
    Age categorical
    Baseline characteristics
    Units: Subjects
        Adults (18-64 years)
    10
    10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    50 ± 11
    40 ± 14
    Gender categorical
    Units: Subjects
        Female
    5
    5
        Male
    5
    5

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 Patients before proceeding to period "Dose finding" or "Dose effect"
    Reporting group title
    Dose finding
    Reporting group description
    		 The dose-titration process was designed as follows. The ini- tial dose in the first patient was set to be sugammadex 0.5 mg kg−1 diluted in 30 ml normal saline. If the TOF ratio remained below 0.9 for the next 5 min, a top-up dose of one-quarter of this dose (e.g. sugammadex 0.125 mg kg−1 in Patient 1) diluted in 10 ml of 0.9% saline was administered. This procedure was re- peated until a stable TOF ratio ≥0.9 (three consecutive measure- ments ≥0.9) was reached in the interventional limb or until a total of four injections were given. If a TOF ratio ≥0.9 was achieved with this titration, the initial and top-up sugammadex doses in the next patient were reduced to one-quarter of the initial dose given to the previous patient but were still diluted in 30 ml saline (10 ml for top-up doses). For example, if the muscle paralysis of Patient 1 was antagonized after the initial dose of sugammadex 0.5 mg kg−1, the initial and the top-up doses would be reduced to 1.25 mg kg−1 in Patient 2.
    Reporting group title
    Dose Effect
    Reporting group description
    		 In this group, dose titration was not performed, and all patients received the same amount of sugammadex diluted in the same volume (30 ml normal saline). The TOF was again measured every 15 s in both arms, and the effects of the sugammadex dose on muscle paralysis in both arms were recorded. The tour- niquet was released 15 min after sugammadex was injected, and the effect of this dose on the TOF values in both arms was re- corded until the TOF ratio returned to ≥0.9 in both arms.

    Subject analysis set title
    Dose finding of sugammadex
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    descriptive

    Subject analysis set title
    Dose to effect
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    descriptive

    Primary: Dose of sugammadex

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    End point title
    		 Dose of sugammadex
    End point description
    End point type
    Primary
    End point timeframe
    5 minutes after the application of sugammadex
    End point values
    		 Dose finding Dose finding of sugammadex
    Number of subjects analysed
    10
    10
    Units: mg/kg
        median (standard deviation)
    0.02 ± 0.15
    0.02 ± 0.15
    Statistical analysis title
    		 descriptive
    Statistical analysis description
    Descriptive analysis
    Comparison groups
    Dose finding v Dose finding of sugammadex
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.05 [2]
    Method
    		 descriptive statistics
    Parameter type
    		 descriptive statistics
    Confidence interval
    Notes
    [1] - descriptive statistics
    [2] - not applicable

    Primary: Time to reversal of rocuronium

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    End point title
    		 Time to reversal of rocuronium
    End point description
    End point type
    Primary
    End point timeframe
    Time from the application of sugammadex to TOF >0.9
    End point values
    		 Dose Effect Dose to effect
    Number of subjects analysed
    10
    10
    Units: minute
        arithmetic mean (standard deviation)
    1.9 ± 1.3
    1.95 ± 1.35
    Statistical analysis title
    		 Time to effect
    Comparison groups
    Dose Effect v Dose to effect
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.05 [3]
    Method
    		 descriptive statistics
    Parameter type
    		 descriptive statistics
    Point estimate
    0
    Confidence interval
         level
    		 0%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Notes
    [3] - not applicable

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    at the day the study was performed
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    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: In this small feasibility study, no adverse event 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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26934944
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