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    Clinical Trial Results:
    A single-blinded multicenter randomized study comparing intubating conditions after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in elderly patients.

    Summary
    EudraCT number
    		 2019-004121-25
    Trial protocol
    		 DK  
    Global end of trial date
    25 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2021
    First version publication date
    27 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NMBA_ELDERLY2019ROCU_REMI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04287426
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Inge Lehmanns Vej 6, Copenhagen, Denmark, 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
    25 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 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 effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years.
    Protection of trial subjects
    All patients received general anaesthesia and postoperative pain treatment
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 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: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    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
    55
    85 years and over
    23

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place between March 2020 and December 2020.

    Pre-assignment
    Screening details
    		 We screened patients above 80 years of age scheduled for elective spine surgery

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    The intervention medicine was prepared outside the operating room and delivered to the clinical staff. The patients, investigators, and surgical staff were unaware of the allocation. Two authors did the data analysis without knowing the allocation as groups were named 0 or 1.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rocuronium
    Arm description
    		 Rocuronium 0.6 mg/kg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    rocuronium
    Investigational medicinal product code
    119302-91-9
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    0.6 mg/kg ideal body weight or actual body weight (the lowest) iv

    Arm title
    		 Remifentanil
    Arm description
    		 Remifentanil 2 microgram pr kg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Remifentanil
    Investigational medicinal product code
    132875-61-7
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Remifentanil 2 microgram pr kg ideal body weight or actual body weight (lowest) iv

    Number of subjects in period 1
    		Rocuronium Remifentanil
    Started
    38
    40
    Completed
    36
    38
    Not completed
    2
    2
         Consent withdrawn by subject
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rocuronium
    Reporting group description
    		 Rocuronium 0.6 mg/kg

    Reporting group title
    Remifentanil
    Reporting group description
    		 Remifentanil 2 microgram pr kg

    Reporting group values
    		 Rocuronium Remifentanil Total
    Number of subjects
    		 38 40 78
    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
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 83 ( 2.4 ) 83 ( 2.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 18 36
        Male
    		 20 22 42
    Subject analysis sets

    Subject analysis set title
    Recruited
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    78 recruited

    Subject analysis sets values
    		 Recruited
    Number of subjects
    78
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    83 ( 2.6 )
    Gender categorical
    Units: Subjects
        Female
    36
        Male
    42

    End points

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    End points reporting groups
    Reporting group title
    Rocuronium
    Reporting group description
    		 Rocuronium 0.6 mg/kg

    Reporting group title
    Remifentanil
    Reporting group description
    		 Remifentanil 2 microgram pr kg

    Subject analysis set title
    Recruited
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    78 recruited

    Primary: Excellent intubating conditions

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    End point title
    		 Excellent intubating conditions
    End point description
    Fuchs-Buder scale
    End point type
    Primary
    End point timeframe
    Two minutes after drug adminstration
    End point values
    		 Rocuronium Remifentanil
    Number of subjects analysed
    36
    38
    Units: Numbers
        Excellent conditions
    10
    15
    Statistical analysis title
    		 Chi Square
    Comparison groups
    Rocuronium v Remifentanil
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.29
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.33

    Secondary: Intervention against hypotension

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    End point title
    		 Intervention against hypotension
    End point description
    Use of ephedrine or phenylephrine as decided by blinded investigator
    End point type
    Secondary
    End point timeframe
    From induction to patient ready for positioning
    End point values
    		 Rocuronium Remifentanil
    Number of subjects analysed
    36
    38
    Units: Yes
        Yes
    24
    28
    Statistical analysis title
    		 Chi Square
    Comparison groups
    Remifentanil v Rocuronium
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.51
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.28

    Secondary: Intubating difficulty score

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    End point title
    		 Intubating difficulty score
    End point description
    End point type
    Secondary
    End point timeframe
    At intubation
    End point values
    		 Rocuronium Remifentanil
    Number of subjects analysed
    36
    38
    Units: IDS score
        median (inter-quartile range (Q1-Q3))
    2 (0.5 to 4.5)
    2 (0 to 4)
    Statistical analysis title
    		 Mann Whitney's rank sum test
    Comparison groups
    Rocuronium v Remifentanil
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.48
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Hoarseness

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    End point title
    		 Hoarseness
    End point description
    End point type
    Secondary
    End point timeframe
    At 24 hours after anaesthesia
    End point values
    		 Rocuronium Remifentanil
    Number of subjects analysed
    36
    38
    Units: Yes
        yes
    13
    13
    Statistical analysis title
    		 Chi square
    Comparison groups
    Rocuronium v Remifentanil
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.86
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.2

    Secondary: Sore throat

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    End point title
    		 Sore throat
    End point description
    End point type
    Secondary
    End point timeframe
    At 24 hours after anaesthesia
    End point values
    		 Rocuronium Remifentanil
    Number of subjects analysed
    36
    38
    Units: Yes
        Yes
    5
    2
    Statistical analysis title
    		 Chi square
    Comparison groups
    Remifentanil v Rocuronium
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.05

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Three days after surgery
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Remifentanil
    Reporting group description
    		 -

    Reporting group title
    Rocuronium
    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 only considered drug-specific AE according to the product summary
    Serious adverse events
    		 Remifentanil Rocuronium
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 38 (21.05%)
    4 / 36 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Prolonged hospitalisation
         subjects affected / exposed
    8 / 38 (21.05%)
    4 / 36 (11.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Remifentanil Rocuronium
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 36 (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? Yes
    Date
    Interruption
    Restart date
    20 Mar 2020
    COVID-19
    20 Apr 2020

    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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