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    Clinical Trial Results:
    The effect of deep neuromuscular block and reversal with sugammadex on surgical conditions and perioperative morbidity in shoulder surgery using a deltopectoral approach

    Summary
    EudraCT number
    		 2018-002961-21
    Trial protocol
    		 BE  
    Global end of trial date
    12 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Aug 2025
    First version publication date
    03 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NS918
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03643913
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat, Leuven, Belgium, 3000
    Public contact
    Clinical Trial Assistant, UZ Leuven, 32 1634 23 64, traumatologie@uzleuven.be
    Scientific contact
    Clinical Trial Assistant, UZ Leuven, 32 1634 23 64, traumatologie@uzleuven.be
    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
    03 Jul 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study evaluates whether deep neuromuscular block during entire surgical procedure to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach results in less muscular damage to the deltoid muscle and therefore less post-operative pain and an earlier functional recovery. The main objective consists of better view and access to the gleno-humeral joint and/or proximal humerus and a decreased early post-operative pain due to less surgical injury to the deltoid muscle.
    Protection of trial subjects
    No fault insurance
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2018
    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
    Belgium: 47
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    35
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients at UZ Leuven - Traumatology scheduled for open surgery via the deltopectoral approach (e.g. Latarjet, osteosynthesis, or prosthesis excl. reverse) will be invited to join the study. Daily OR schedules are screened; eligible patients are assessed by a physician and informed consent is obtained.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Moderate
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bridion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    2 mg/kg

    Arm title
    		 Deep
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bridion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 mg/kg

    Number of subjects in period 1
    		Moderate Deep
    Started
    24
    23
    Completed
    24
    23

    Baseline characteristics

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

    Reporting group title
    Deep
    Reporting group description
    		 -

    Reporting group values
    		 Moderate Deep Total
    Number of subjects
    		 24 23 47
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 50 (32.5 to 66) 56 (37 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 9 11 20
        Male
    		 15 12 27

    End points

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

    Reporting group title
    Deep
    Reporting group description
    		 -

    Primary: Surgical conditions

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    End point title
    		 Surgical conditions
    End point description
    End point type
    Primary
    End point timeframe
    Post-operative
    End point values
    		 Moderate Deep
    Number of subjects analysed
    24
    23
    Units: Modified leiden score
        arithmetic mean (standard deviation)
    2.75 ( 1.860 )
    2.43 ( 1.903 )
    Statistical analysis title
    		 Mann–Whitney U test
    Comparison groups
    Moderate v Deep
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Post-operative pain

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    End point title
    		 Post-operative pain
    End point description
    End point type
    Primary
    End point timeframe
    Day 3 post-op
    End point values
    		 Moderate Deep
    Number of subjects analysed
    24
    23
    Units: VAS
        arithmetic mean (full range (min-max))
    3 (1 to 4)
    3 (2 to 4)
    Statistical analysis title
    		 Mann–Whitney U test
    Comparison groups
    Moderate v Deep
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Muscle damage

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    End point title
    		 Muscle damage
    End point description
    End point type
    Secondary
    End point timeframe
    Post-operative
    End point values
    		 Moderate Deep
    Number of subjects analysed
    24
    23
    Units: Deltoid muscle injury
        median (full range (min-max))
    2 (1 to 4)
    2 (1 to 3)
    No statistical analyses for this end point

    Secondary: Length of stay at post-anesthesia care unit

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    End point title
    		 Length of stay at post-anesthesia care unit
    End point description
    End point type
    Secondary
    End point timeframe
    Post-operative
    End point values
    		 Moderate Deep
    Number of subjects analysed
    24
    23
    Units: Minutes
        median (full range (min-max))
    106.5 (60 to 224)
    114 (52 to 243)
    No statistical analyses for this end point

    Secondary: Length of stay at hopsital after surgery

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    End point title
    		 Length of stay at hopsital after surgery
    End point description
    End point type
    Secondary
    End point timeframe
    Post-operative
    End point values
    		 Moderate Deep
    Number of subjects analysed
    24
    23
    Units: Days
        median (full range (min-max))
    2 (1 to 8)
    3 (2 to 8)
    No statistical analyses for this end point

    Secondary: Surgical time

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    End point title
    		 Surgical time
    End point description
    End point type
    Secondary
    End point timeframe
    Peri-operative
    End point values
    		 Moderate Deep
    Number of subjects analysed
    24
    23
    Units: minute
        median (full range (min-max))
    69.5 (46 to 163)
    76 (38 to 158)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    20250301
    Reporting groups
    Reporting group title
    Moderate
    Reporting group description
    		 -

    Reporting group title
    Deep
    Reporting group description
    		 -

    Serious adverse events
    		 Moderate Deep
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism and partial atelectasis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (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
    		 Moderate Deep
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
    3 / 23 (13.04%)
    Vascular disorders
    High blood pressure
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Higher doses bridion needed than anticipated
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Rash
    Additional description: Itchy rash in neck
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Panic attack
    Additional description: Panic attack about numb arm
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Hematoma
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Nov 2018
    Raising the maximum age limit from 75 to 85 years to improve patient inclusion.
    19 Jul 2021
    This amendment aims to extend the study end date from July 2021 to July 2022.
    01 Apr 2022
    The amendment includes a change of PI at UZ Leuven, with Prof. Harm Hoekstra taking over the role from March 14, 2022.
    12 Mar 2024
    This amendment aims to extend the study end date from July 2022 to December 31 2024.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Mar 2020
    Temporary interruption due to the COVID-19 pandemic.
    03 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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