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    Clinical Trial Results:
    Efficacy of profound versus moderate neuromuscular blockade in enhancing postoperative recovery after laparoscopic donor nephrectomy - a rondomised controlled trial

    Summary
    EudraCT number
    2016-002924-99
    Trial protocol
    NL  
    Global end of trial date
    18 Dec 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Feb 2020
    First version publication date
    13 Feb 2020
    Other versions
    Summary report(s)
    RELAX-1 article

    Trial information

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    Trial identification
    Sponsor protocol code
    NL.58160.091.16
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02838134
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands, 6525 GA
    Public contact
    RELAX information, Radboudumc, +31 243615333, Michiel.Warle@radboudumc.nl
    Scientific contact
    RELAX information, Radboudumc, +31 243615333, Michiel.Warle@radboudumc.nl
    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
    18 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) -with standard pressure pneumoperitoneum- and the early quality of recovery.
    Protection of trial subjects
    In accordance to section 10, subsection 4, of the WMO, the investigator will inform the subjects and the reviewing accredited METC if anything occurs, on the basis of which it appears that the disadvantages of participation may be significantly greater than was foreseen in the research proposal. The study will be suspended pending further review by the accredited METC, except insofar as suspension would jeopardise the subjects’ health. The investigator will take care that all subjects are kept informed.
    Background therapy
    induction with remifentanil, propofol and rocuronium (intubation dose 0.6 mg/kg). Anesthesia is aimed at a bispectral index score between 45-55. Tracheal intubation is performed 2 minutes after administration of 0.6 mg/kg rocuronium in both groups. In case of a BMI>30 kg/m2 the dose rocuronium will be adjusted taking into account ideal body weight.
    Evidence for comparator
    Rocuronium bromide is administered intravenously (i.v.) either as a bolus injection or as a continuous infusion. The standard intubating dose during routine anaesthesia is 0.6 mg rocuronium bromide per kg body weight, which results in adequate intubation conditions within 60 seconds in nearly all patients.
    Actual start date of recruitment
    01 Aug 2016
    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
    Netherlands: 96
    Worldwide total number of subjects
    96
    EEA total number of subjects
    96
    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)
    75
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 127 living kidney donors were screened for enrolment, 18 patients refused consent, seven patients were excluded because of insufficient command of the Dutch language and one patient was excluded because of chronic use of psychotropic drugs. A total of 50 patients were allocated to profound NMB and 51 patients to moderate NMB.

    Pre-assignment
    Screening details
    A total of 96 patients will be randomised, based on a computer-generated list, to either deep NMB (group A) or moderate NMB (group B). Stratification by centre will be used. All adult individuals (>18 years), who are scheduled for living kidney donation are eligible for this study.

    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, Monitor, Data analyst, Carer
    Blinding implementation details
    Before the surgeons arrive at the operation room, all study medications are prepared by the anaesthesiologist or the anaesthesiologist’s assistant, after opening the envelope containing the allocation of treatment. Surgeons, scrub nurses, and research physician are blinded for group allocation. Covering of the neuromuscular monitoring equipment, nerve stimulator and computer behind sterile drapes ensures this. The attending anaesthetic staff in the operating room are not blinded as the anaesthe

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Deep neuromuscular block/group A
    Arm description
    A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.
    Arm type
    Experimental

    Investigational medicinal product name
    Esmeron
    Investigational medicinal product code
    SUB10353MIG
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.

    Investigational medicinal product name
    Bridion
    Investigational medicinal product code
    SUB26695
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    After skin closure, the NMB is reversed with sugammadex using 4 mg/kg

    Arm title
    Moderate neuromuscular block/group B
    Arm description
    No additional rocuronium is administered after tracheal intubation.
    Arm type
    Active comparator

    Investigational medicinal product name
    Esmeron
    Investigational medicinal product code
    SUB10353MIG
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation. no additional rocuronium is administered after tracheal intubation and the neuromuscular function was allowed to recover spontaneously.

    Investigational medicinal product name
    Bridion
    Investigational medicinal product code
    SUB26695
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    After skin closure, the NMB is reversed with sugammadex using 2 mg/kg

    Number of subjects in period 1
    Deep neuromuscular block/group A Moderate neuromuscular block/group B
    Started
    48
    48
    Completed
    48
    48

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Reporting group values
    overall trial Total
    Number of subjects
    96 96
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    75 75
        From 65-84 years
    21 21
        85 years and over
    0 0
    Age continuous
    whole group
    Units: years
        arithmetic mean (standard deviation)
    55.86 ( 9.830 ) -
    Gender categorical
    Units: Subjects
        Female
    51 51
        Male
    45 45
        Not recorded
    0 0
    Subject analysis sets

    Subject analysis set title
    As-treated analysis: moderate block
    Subject analysis set type
    Per protocol
    Subject analysis set description
    In the as-treated analysis, we combined the patients with PTC 1to 3 and patients with TOF count 0 and PTC at least 4 in the profound NMB group. The five patients (10.4%) in which a TOF count 0 wasn’t achieved, were analysed as moderate NMB. The two patients in the profound NMB group with missing data on their level of NMB were excluded from the as-treated analysis.

    Subject analysis set title
    As treated analysis - deep block
    Subject analysis set type
    Per protocol
    Subject analysis set description
    In the as-treated analysis, we combined the patients with PTC 1to 3 and patients with TOF count 0 and PTC at least 4 in the profound NMB group. The five patients (10.4%) in which a TOF count 0 wasn’t achieved, were analysed as moderate NMB. The two patients in the profound NMB group with missing data on their level of NMB were excluded from the as-treated analysis.

    Subject analysis sets values
    As-treated analysis: moderate block As treated analysis - deep block
    Number of subjects
    53
    41
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    41
    32
        From 65-84 years
    12
    9
        85 years and over
    0
    0
    Age continuous
    whole group
    Units: years
        arithmetic mean (standard deviation)
    56.53 ( 9.557 )
    56.22 ( 9.671 )
    Gender categorical
    Units: Subjects
        Female
    28
    21
        Male
    25
    20
        Not recorded
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Deep neuromuscular block/group A
    Reporting group description
    A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.

    Reporting group title
    Moderate neuromuscular block/group B
    Reporting group description
    No additional rocuronium is administered after tracheal intubation.

    Subject analysis set title
    As-treated analysis: moderate block
    Subject analysis set type
    Per protocol
    Subject analysis set description
    In the as-treated analysis, we combined the patients with PTC 1to 3 and patients with TOF count 0 and PTC at least 4 in the profound NMB group. The five patients (10.4%) in which a TOF count 0 wasn’t achieved, were analysed as moderate NMB. The two patients in the profound NMB group with missing data on their level of NMB were excluded from the as-treated analysis.

    Subject analysis set title
    As treated analysis - deep block
    Subject analysis set type
    Per protocol
    Subject analysis set description
    In the as-treated analysis, we combined the patients with PTC 1to 3 and patients with TOF count 0 and PTC at least 4 in the profound NMB group. The five patients (10.4%) in which a TOF count 0 wasn’t achieved, were analysed as moderate NMB. The two patients in the profound NMB group with missing data on their level of NMB were excluded from the as-treated analysis.

    Primary: Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)

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    End point title
    Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)
    End point description
    The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome
    End point type
    Primary
    End point timeframe
    24 hours after detubation
    End point values
    Deep neuromuscular block/group A Moderate neuromuscular block/group B As-treated analysis: moderate block As treated analysis - deep block
    Number of subjects analysed
    47 [1]
    47 [2]
    52
    40
    Units: Total score
        arithmetic mean (standard deviation)
    169.3 ( 18.3 )
    169.5 ( 15.5 )
    168.7 ( 15.9 )
    171.1 ( 18.3 )
    Attachments
    QoR-40 questionnaire
    Notes
    [1] - 1 patient missed one page of the QR-40 questionnaire on postoperative day 1
    [2] - 1 patient did not complete the questionnaires on postoperative day 1 and 2
    Statistical analysis title
    QoR-40
    Comparison groups
    Deep neuromuscular block/group A v Moderate neuromuscular block/group B
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    t-test, 2-sided
    Confidence interval

    Secondary: Postoperative pain

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    End point title
    Postoperative pain
    End point description
    Overall maximum painscore
    End point type
    Secondary
    End point timeframe
    Postoperative day 1
    End point values
    Deep neuromuscular block/group A Moderate neuromuscular block/group B As-treated analysis: moderate block As treated analysis - deep block
    Number of subjects analysed
    48
    47 [3]
    52
    41
    Units: NRS
        arithmetic mean (standard deviation)
    5.0 ( 2.3 )
    5.6 ( 2.1 )
    5.7 ( 2.1 )
    4.7 ( 2.3 )
    Attachments
    Postoperative pain
    Notes
    [3] - 1 patient did not complete the questionaires on postoperative day 1 and 2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from admission until 60 days after surgery
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    toetsingonline.nl
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Deep neuromuscular block/group A
    Reporting group description
    A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.

    Reporting group title
    Moderate neuromuscular block/group B
    Reporting group description
    No additional rocuronium is administered after tracheal intubation.

    Serious adverse events
    Deep neuromuscular block/group A Moderate neuromuscular block/group B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Infection
    Additional description: Readmission because of urinary tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Deep neuromuscular block/group A Moderate neuromuscular block/group B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 48 (18.75%)
    5 / 48 (10.42%)
    General disorders and administration site conditions
    hypertension
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Infections and infestations
    Infection
    Additional description: UTI, epididymitis, woundinfection or other
         subjects affected / exposed
    8 / 48 (16.67%)
    4 / 48 (8.33%)
         occurrences all number
    8
    4

    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/30920983
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