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    Clinical Trial Results:
    Optimizing surgical conditions during laparoscopic umbilical, incisional –and linea alba herniotomy with deep neuromuscular blockade (The hernia study)

    Summary
    EudraCT number
    		 2014-002802-19
    Trial protocol
    		 DK  
    Global end of trial date
    25 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jul 2022
    First version publication date
    21 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NMBDKHernia2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02247466
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Herlev Ringvej, Herlev, Denmark,
    Public contact
    Mona Ring Gätke, Department of Anaesthesiology, mona.gatke@regionh.dk
    Scientific contact
    Mona Ring Gätke, Department of Anaesthesiology, mona.gatke@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
    28 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary outcome: Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg.
    Protection of trial subjects
    Postoperative pain treatment comprised paracetamol, NSAID and morphine according to local guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2015
    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: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were enrolled by an investigator before surgery. Eligible patients were more than 18 years of age scheduled for elective laparoscopic ventral hernia repair.

    Pre-assignment
    Screening details
    		 exclusion criteria were known allergy to sugammadex, mivacurium or rocuronium, severe renal disease, neuromuscular disease, lactating or pregnant women

    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
    Blinding implementation details
    The patient’s hand, the nerve stimulator and computer were concealed from the surgeon and the surgical staff. An investigator prepared the intervention medicine in coded syringes before surgery so that the surgical team was blind to the medication. During surgery, the unblinded investigator was responsible for NMB monitoring and administration of the study drugs.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Saline Rocuronium
    Arm description
    		 In group A, patients received a bolus of 3ml of saline and 3 min later the surgeon evaluated the surgical view using a five-point subjective rating scale,16 ranging from 5 (optimal) to 1 (worst), refer to Table 1. Next, a bolus of rocuronium 0.6 mgkg1 was administered, and 3 min later when TOF¼0 was reached, the PTC was measured, and the surgeon re-evaluated the surgical view.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    rocuronium
    Investigational medicinal product code
    25246
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    rocuronium 0.6 mg/kg intravenous

    Arm title
    		 rocuronium sugammadex
    Arm description
    		 In Group B, a bolus of rocuronium 0.6mg/kg was administered and 3 min later when TOF 0 was reached, the PTC was measured and the surgeon evaluated the surgical view using the five-point rating scale. Sugammadex was then administered, 4 to 16mg/kg according to depth of NMB, and 3 min later, the surgeon re-evaluated the surgical view throughout the surgery until last suture boluses of saline (placebo) were administered. During suturing of the hernial defect, surgical conditions were assessed using the five-point rating scale. At the end of surgery, NMB was reversed in all patients
    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
    A bolus of rocuronium 0.6mg/kg was administered and 3 min later when TOF 0 was reached, the PTC was measured and the surgeon evaluated the surgical view using the five-point rating scale. Sugammadex was then administered, 4 to 16 mg/kg.

    Number of subjects in period 1
    		Saline Rocuronium rocuronium sugammadex
    Started
    19
    15
    Completed
    19
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Saline Rocuronium
    Reporting group description
    		 In group A, patients received a bolus of 3ml of saline and 3 min later the surgeon evaluated the surgical view using a five-point subjective rating scale,16 ranging from 5 (optimal) to 1 (worst), refer to Table 1. Next, a bolus of rocuronium 0.6 mgkg1 was administered, and 3 min later when TOF¼0 was reached, the PTC was measured, and the surgeon re-evaluated the surgical view.

    Reporting group title
    rocuronium sugammadex
    Reporting group description
    		 In Group B, a bolus of rocuronium 0.6mg/kg was administered and 3 min later when TOF 0 was reached, the PTC was measured and the surgeon evaluated the surgical view using the five-point rating scale. Sugammadex was then administered, 4 to 16mg/kg according to depth of NMB, and 3 min later, the surgeon re-evaluated the surgical view throughout the surgery until last suture boluses of saline (placebo) were administered. During suturing of the hernial defect, surgical conditions were assessed using the five-point rating scale. At the end of surgery, NMB was reversed in all patients

    Reporting group values
    		 Saline Rocuronium rocuronium sugammadex Total
    Number of subjects
    		 19 15 34
    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)
    		 19 15 34
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57 ± 17 55 ± 15 -
    Gender categorical
    Units: Subjects
        Female
    		 4 5 9
        Male
    		 15 10 25

    End points

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    End points reporting groups
    Reporting group title
    Saline Rocuronium
    Reporting group description
    		 In group A, patients received a bolus of 3ml of saline and 3 min later the surgeon evaluated the surgical view using a five-point subjective rating scale,16 ranging from 5 (optimal) to 1 (worst), refer to Table 1. Next, a bolus of rocuronium 0.6 mgkg1 was administered, and 3 min later when TOF¼0 was reached, the PTC was measured, and the surgeon re-evaluated the surgical view.

    Reporting group title
    rocuronium sugammadex
    Reporting group description
    		 In Group B, a bolus of rocuronium 0.6mg/kg was administered and 3 min later when TOF 0 was reached, the PTC was measured and the surgeon evaluated the surgical view using the five-point rating scale. Sugammadex was then administered, 4 to 16mg/kg according to depth of NMB, and 3 min later, the surgeon re-evaluated the surgical view throughout the surgery until last suture boluses of saline (placebo) were administered. During suturing of the hernial defect, surgical conditions were assessed using the five-point rating scale. At the end of surgery, NMB was reversed in all patients

    Primary: difference in the surgical view

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    End point title
    		 difference in the surgical view [1]
    End point description
    End point type
    Primary
    End point timeframe
    Immediately
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was analyzed as a paired design
    End point values
    		 Saline Rocuronium rocuronium sugammadex
    Number of subjects analysed
    19
    15
    Units: score
        arithmetic mean (full range (min-max))
    0.21 (0 to 2)
    -0.06 (-2 to 2)
    No statistical analyses for this end point

    Secondary: suturing hernia

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    End point title
    		 suturing hernia
    End point description
    subjective assessment of suturing the defect using a five point rating scale. 0 worst, 5 optimal.
    End point type
    Secondary
    End point timeframe
    during suture of the defect
    End point values
    		 Saline Rocuronium rocuronium sugammadex
    Number of subjects analysed
    19
    15
    Units: score
        arithmetic mean (standard deviation)
    4.8 ± 0.4
    4.0 ± 1.4
    Statistical analysis title
    		 suture hernia defect
    Comparison groups
    Saline Rocuronium v rocuronium sugammadex
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: duration of hernia suturing

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    End point title
    		 duration of hernia suturing
    End point description
    End point type
    Secondary
    End point timeframe
    during suturing of hernia
    End point values
    		 Saline Rocuronium rocuronium sugammadex
    Number of subjects analysed
    19
    15
    Units: minutes
        arithmetic mean (standard deviation)
    10 ± 9
    9 ± 7
    Statistical analysis title
    		 suture hernia defect
    Comparison groups
    rocuronium sugammadex v Saline Rocuronium
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were reported according to agreement with the Danish Medicines Agency and monitored by the Good Clinical Research Practice Unit at Copenhagen University Hospitals
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Adverse events were monitored according to agreement with the Danish Medicines Agency and monitored by the GCP unit at Copenhagen University Hospital

    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/29878947
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