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    Clinical Trial Results:
    A single blinded multicenter randomized study comparing intubating conditions during rapid sequence induction with either suxamethonium 1.0 mg/kg or rocuronium 1.0 mg/kg in elderly patients (≥ 80 years old)

    Summary
    EudraCT number
    		 2020-005384-31
    Trial protocol
    		 DK  
    Global end of trial date
    08 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2025
    First version publication date
    29 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RSIv80
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet University of Copenhagen
    Sponsor organisation address
    Inge Lehmanns Vej 7, Copenhagen, Denmark, 2100
    Public contact
    Department of Anesthesia, Rigshospitalet, 45 35457547, matias.vested@regionh.dk
    Scientific contact
    Department of Anesthesia, Rigshospitalet, 45 35457547, matias.vested@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
    07 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Feb 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2024
    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 proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years.
    Protection of trial subjects
    Patients were anesthetised and received standardised pain treatment according to local guidelines
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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
    90
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 We included patients 80 years or above with American Society of Anesthesiologists (ASA) physical health class I to IV, scheduled for surgery under general anesthesia with indication for RSI intubation, and a body mass index (BMI) < 35 kg/m2.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rocuronium
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    rocuronium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    1 mg/kg

    Arm title
    		 Suxamethonium
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    suxamethonium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    suxamethonium 1 mg/kg

    Number of subjects in period 1
    		Rocuronium Suxamethonium
    Started
    49
    41
    Completed
    49
    41

    Baseline characteristics

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

    Reporting group title
    Suxamethonium
    Reporting group description
    		 -

    Reporting group values
    		 Rocuronium Suxamethonium Total
    Number of subjects
    		 49 41 90
    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 ( 3 ) 84 ( 3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 22 50
        Male
    		 21 19 40

    End points

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    End points reporting groups
    Reporting group title
    Rocuronium
    Reporting group description
    		 -

    Reporting group title
    Suxamethonium
    Reporting group description
    		 -

    Primary: optimal intubating conditions

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    End point title
    		 optimal intubating conditions
    End point description
    End point type
    Primary
    End point timeframe
    From start of anaesthesia till tracheal intubation within 15 minutes
    End point values
    		 Rocuronium Suxamethonium
    Number of subjects analysed
    49
    41
    Units: number
    36
    31
    Statistical analysis title
    		 Qi square test for proportions
    Comparison groups
    Rocuronium v Suxamethonium
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: time to tracheal intubation

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    End point title
    		 time to tracheal intubation
    End point description
    End point type
    Secondary
    End point timeframe
    from start of anaesthesia till tracheal intubation
    End point values
    		 Rocuronium Suxamethonium
    Number of subjects analysed
    49
    41
    Units: minute
        arithmetic mean (standard deviation)
    159 ( 33 )
    154 ( 31 )
    Statistical analysis title
    		 t test
    Comparison groups
    Rocuronium v Suxamethonium
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from start of anaesthesia till 3 days postoperatively
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Rocuronium
    Reporting group description
    		 -

    Reporting group title
    Suxamethonium
    Reporting group description
    		 -

    Serious adverse events
    		 Rocuronium Suxamethonium
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 49 (14.29%)
    1 / 41 (2.44%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    bleeding
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    impaired vision
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Desaturation
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    muscle weakness
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    fever
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 41 (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: 0%
    Non-serious adverse events
    		 Rocuronium Suxamethonium
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 49 (22.45%)
    17 / 41 (41.46%)
    Cardiac disorders
    ECG changes
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Edema
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 41 (4.88%)
         occurrences all number
    1
    2
    Eye disorders
    Double vision
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    bronchospasm
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Postopeative muscle weakness
         subjects affected / exposed
    7 / 49 (14.29%)
    12 / 41 (29.27%)
         occurrences all number
    7
    12

    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/39910022
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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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