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    Clinical Trial Results:
    Muscle relaxation during open upper abdominal surgery -can the surgical conditions be optimized? (The laparotomy study) Influence of deep neuromuscular blockade on the surgeons´ assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex

    Summary
    EudraCT number
    		 2014-001155-22
    Trial protocol
    		 DK  
    Global end of trial date
    04 Aug 2016

    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
    Lap2014NMB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02140593
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Herlev Ringvej, Herlev, Denmark,
    Public contact
    Department of Anesthesiology, Mona Ring Gätke, mona.gatke@regionh.dk
    Scientific contact
    Department of Anesthesiology, Mona Ring Gätke, 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
    01 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery. Hypothesis: Intense NMB (PTC 0-1) compared to standard NMB improves average of surgical condition scores evaluated on a subjective rating scale.
    Protection of trial subjects
    An epidural catheter was placed preoperatively, and a test dose of 3 ml of lidocaine 20 mg ml-1 with adrenalin was installed. No further medicine was given in the epidural catheter until after closure of the abdominal wall. Anaesthesia was induced with propofol 2 mg kg-1 and remifentanil 1.0 µg kg-1 min-1. Anaesthesia was maintained with propofol 0.5 mg kg-1 hour-1 and remifentanil 0.25-0.5 µg kg-1 min-1, and adjusted according to depth of anaesthesia under guidance of arterial blood pressure and entropy 30-50 (Entropy Sensor, GE Healthcare, Hillerød, Denmark). The protocol allowed change to sevoflurane anaesthesia during surgery if the attending anaesthesiologist deemed this necessary.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 May 2014
    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: 128
    Worldwide total number of subjects
    128
    EEA total number of subjects
    128
    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)
    56
    From 65 to 84 years
    71
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients aged > 18 years scheduled for elective open upper abdominal surgery (Whipple, gastrectomy, splenectomy, gastric resection, liver resection and laparotomies due to bile obstruction, i.e. hepaticojejunostomy (not cholecystectomy)) were eligible.

    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
    Intervention medicine was prepared in the operating room before surgery under double control by a nurse anaesthetist and by the investigator who also performed the randomization. The TOF-Watch and the arm with the neuromuscular equipment were covered and the readings from the TOF-Watch were only seen on the connected computer by the nurse anaesthetist and the investigator. The surgeon and any surgical personnel were blinded to the patients’ group allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Deep NMB
    Arm description
    		 Deep neuromuscular blockade
    Arm type
    		 Experimental

    Investigational medicinal product name
    rocuronium
    Investigational medicinal product code
    25246
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Endotracheal intubation was performed two minutes after administration of rocuronium 0.6 mg kg-1. In group DEEP after tracheal intubation patients received rocuronium infusion (2 mg ml-1) with a target level of PTC 0-1. Just before skin incision, 1 ml of saline (placebo) was administered.

    Arm title
    		 Standard NMB
    Arm description
    		 Standard neuromuscular blockade
    Arm type
    		 standard treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Deep NMB Standard NMB
    Started
    65
    63
    Completed
    65
    63

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Deep NMB
    Reporting group description
    		 Deep neuromuscular blockade

    Reporting group title
    Standard NMB
    Reporting group description
    		 Standard neuromuscular blockade

    Reporting group values
    		 Deep NMB Standard NMB Total
    Number of subjects
    		 65 63 128
    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 (full range (min-max))
    		 63 (31 to 78) 65 (35 to 85) -
    Gender categorical
    Units: Subjects
        Female
    		 26 30 56
        Male
    		 39 33 72

    End points

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    End points reporting groups
    Reporting group title
    Deep NMB
    Reporting group description
    		 Deep neuromuscular blockade

    Reporting group title
    Standard NMB
    Reporting group description
    		 Standard neuromuscular blockade

    Primary: surgical rating scale

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    End point title
    		 surgical rating scale
    End point description
    End point type
    Primary
    End point timeframe
    During surgery
    End point values
    		 Deep NMB Standard NMB
    Number of subjects analysed
    65
    63
    Units: score
    median (standard deviation)
        surgical rating score
    4.75 ± 0.54
    4 ± 0.91
    Statistical analysis title
    		 Mann-Whitney
    Statistical analysis description
    the Mann-Whitney test was used to compare ordinal or continuous variables that were not normally distributed
    Comparison groups
    Deep NMB v Standard NMB
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    September 2014 and May 2016
    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 Danish Medicines Agency and monitored by the GCP unit.

    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/29040455
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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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