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    Clinical Trial Results:
    A single-blinded multicenter randomized interventional study of rocuronium 0.3 mg/kg, and 0.9 mg/kg comparing onset time, duration of action and effect on intubating conditions in elderly patients (≥ 80 years).

    Summary
    EudraCT number
    		 2019-004343-76
    Trial protocol
    		 DK  
    Global end of trial date
    21 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2021
    First version publication date
    14 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NMBA_ELDERLY2019ROCU_DOSES
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04512313
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Inge Lehmanns Vej 6, Copenhagen, Denmark, DK-2100
    Public contact
    Department of Anaesthesia, Rigshospitalet, 45 35458043, lars.rasmussen.01@regionh.dk
    Scientific contact
    Department of Anaesthesia, Rigshospitalet, 61652212 35458043, lars.rasmussen.01@regionh.dk
    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 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to determine the onset time after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.
    Protection of trial subjects
    All subjects received anaesthesia and analgesia according to best practice and the Helsinki Declaration
    Background therapy
    		 Propofol and fentanyl for induction of anaesthesia. Postoperative pain relief with multimodal analgesia
    Evidence for comparator
    		 Previous studies have found longer onset of rocuronium in elderly if only 0.6 mg pr kg is used. We therefore wanted to test if tracheal intubation could be performed earlier with better conditions with a larger dose 0.9 mg/kg. This large dose would be expected to result in a very long duration of action so we decided to compare with a smaller dose of 0.3 mg/kg.
    Actual start date of recruitment
    17 Dec 2020
    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
    Denmark: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    0
    From 65 to 84 years
    23
    85 years and over
    14

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 37 elderly were recruited between 17 December 2020 and 21 May 2021 in Copenhagen, Denmark

    Pre-assignment
    Screening details
    		 We screened patients above 80 years of age scheduled for elective surgery with anticipated duration of more than one hour. Other inclusion criteria were ASA group I to III, total intravenous anaesthesia and use of tracheal intubation after rocuronium.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The allocation sequence was generated by a computer program (REDCap) and rocuronium was prepared by an investigator who drew up the drug in 10 ml syringes of equal volume. The attending anesthetist, the patient, and the other investigators were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rocuronium 0.3 mg/kg
    Arm description
    		 Rocuronium 0.3 mg/kg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rocuronium
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Rocuronium 0.3 mg/kg was given after anaesthesia induction

    Arm title
    		 Rocuronium 0.9 mg/kg
    Arm description
    		 Rocuronium 0.9 mg/kg was given after anaesthesia induction
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rocuronium
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Rocuronium 0.9 mg/kg was given after anaesthesia induction

    Number of subjects in period 1
    		Rocuronium 0.3 mg/kg Rocuronium 0.9 mg/kg
    Started
    20
    17
    Completed
    18
    16
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    -
         Logistic
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rocuronium 0.3 mg/kg
    Reporting group description
    		 Rocuronium 0.3 mg/kg

    Reporting group title
    Rocuronium 0.9 mg/kg
    Reporting group description
    		 Rocuronium 0.9 mg/kg was given after anaesthesia induction

    Reporting group values
    		 Rocuronium 0.3 mg/kg Rocuronium 0.9 mg/kg Total
    Number of subjects
    		 20 17 37
    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)
    		 0 0 0
        From 65-84 years
    		 16 7 23
        85 years and over
    		 4 10 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 83 ± 1.9 85 ± 3.3 -
    Gender categorical
    Units: Subjects
        Female
    		 10 13 23
        Male
    		 10 4 14
    ASA class
    ASA class
    Units: Subjects
        ASA II
    		 9 10 19
        ASA III
    		 11 7 18
    Subject analysis sets

    Subject analysis set title
    Intubated
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Those intubated

    Subject analysis sets values
    		 Intubated
    Number of subjects
    34
    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
    20
        85 years and over
    14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    Gender categorical
    Units: Subjects
        Female
        Male
    ASA class
    ASA class
    Units: Subjects
        ASA II
        ASA III

    End points

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    End points reporting groups
    Reporting group title
    Rocuronium 0.3 mg/kg
    Reporting group description
    		 Rocuronium 0.3 mg/kg

    Reporting group title
    Rocuronium 0.9 mg/kg
    Reporting group description
    		 Rocuronium 0.9 mg/kg was given after anaesthesia induction

    Subject analysis set title
    Intubated
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Those intubated

    Primary: Onset time

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    End point title
    		 Onset time
    End point description
    End point type
    Primary
    End point timeframe
    From injection of rocuronium until TOF=0
    End point values
    		 Rocuronium 0.3 mg/kg Rocuronium 0.9 mg/kg
    Number of subjects analysed
    6
    16
    Units: seconds
        arithmetic mean (standard deviation)
    227 ± 140
    108 ± 40
    Statistical analysis title
    		 onset time difference
    Statistical analysis description
    t-test
    Comparison groups
    Rocuronium 0.3 mg/kg v Rocuronium 0.9 mg/kg
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    119
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 41
         upper limit
    		 196

    Secondary: Duration of action

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    End point title
    		 Duration of action
    End point description
    End point type
    Secondary
    End point timeframe
    From rocuronium injection to TOF 0.9
    End point values
    		 Rocuronium 0.3 mg/kg Rocuronium 0.9 mg/kg
    Number of subjects analysed
    16
    11
    Units: Minutes
        arithmetic mean (standard deviation)
    46 ± 13
    118 ± 43
    Statistical analysis title
    		 Duration of action
    Comparison groups
    Rocuronium 0.3 mg/kg v Rocuronium 0.9 mg/kg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49
         upper limit
    		 95

    Secondary: IDS

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    End point title
    		 IDS
    End point description
    End point type
    Secondary
    End point timeframe
    At intubation
    End point values
    		 Rocuronium 0.3 mg/kg Rocuronium 0.9 mg/kg
    Number of subjects analysed
    18
    16
    Units: score
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    1 (0 to 2)
    Statistical analysis title
    		 IDS comparison
    Statistical analysis description
    Intubation difficulty score
    Comparison groups
    Rocuronium 0.3 mg/kg v Rocuronium 0.9 mg/kg
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.18
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Proportion with excellent intubation conditions

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    End point title
    		 Proportion with excellent intubation conditions
    End point description
    Excellent intubation conditions according to Fuchs Buder
    End point type
    Secondary
    End point timeframe
    At intubation
    End point values
    		 Rocuronium 0.3 mg/kg Rocuronium 0.9 mg/kg Intubated
    Number of subjects analysed
    18
    16
    34
    Units: Numbers
        Yes
    4
    11
    15
        No
    14
    5
    19
    Statistical analysis title
    		 Comparing proportions with excellent conditions
    Comparison groups
    Rocuronium 0.3 mg/kg v Rocuronium 0.9 mg/kg
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 0.77

    Secondary: Use of videolaryngoscope

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    End point title
    		 Use of videolaryngoscope
    End point description
    End point type
    Secondary
    End point timeframe
    At intubation
    End point values
    		 Rocuronium 0.3 mg/kg Rocuronium 0.9 mg/kg Intubated
    Number of subjects analysed
    18
    16
    34
    Units: Numbers
        Yes
    8
    6
    14
        No
    10
    10
    20
    Statistical analysis title
    		 Comparing use of videolaryngoscope
    Comparison groups
    Rocuronium 0.3 mg/kg v Rocuronium 0.9 mg/kg
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.68
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.4

    Secondary: Use of stylet

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    End point title
    		 Use of stylet
    End point description
    End point type
    Secondary
    End point timeframe
    At intubation
    End point values
    		 Rocuronium 0.3 mg/kg Rocuronium 0.9 mg/kg
    Number of subjects analysed
    18
    16
    Units: Numbers
        Yes
    9
    6
        No
    9
    10
    Statistical analysis title
    		 Comparing use of stylet
    Comparison groups
    Rocuronium 0.3 mg/kg v Rocuronium 0.9 mg/kg
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.46
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.46

    Secondary: IDS score above 0

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    End point title
    		 IDS score above 0
    End point description
    End point type
    Secondary
    End point timeframe
    At intubation
    End point values
    		 Rocuronium 0.3 mg/kg Rocuronium 0.9 mg/kg
    Number of subjects analysed
    18
    16
    Units: Numbers
        Yes
    4
    6
        No
    14
    10
    Statistical analysis title
    		 Comparing proportions with IDS>0
    Comparison groups
    Rocuronium 0.9 mg/kg v Rocuronium 0.3 mg/kg
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.33
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.45

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    7 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Rocuronium 0.9 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Rocuronium 0.3 mg/kg
    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: We carefully examined potential adverse events according to the data on rocuronium
    Serious adverse events
    		 Rocuronium 0.9 mg/kg Rocuronium 0.3 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Constipation
    Additional description: Readmitted with constipation and hyponatremia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rocuronium 0.9 mg/kg Rocuronium 0.3 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 18 (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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    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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