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    Clinical Trial Results:
    A Randomized, Assessor-blind, Dose-ranging, Phase IIIB, Multicenter Trial Comparing the Intubating Conditions and Time Course of Block of Three Different Intubating Doses (0.45 mg/kg, 0.6 mg/kg, and 1.0 mg/kg) of Zemuron® in Pediatric and Adolescent Subjects Under General Anesthesia

    Summary
    EudraCT number
    		 2005-002928-34
    Trial protocol
    		 BE   Outside EU/EEA  
    Global end of trial date
    26 Jul 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Mar 2019
    First version publication date
    17 Mar 2016
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    P05798
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00124722
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Registration number: MK-8085-002, Organon Registration number: 021049
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jul 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous (IV) bolus doses of Zemuron (rocuronium bromide) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) in term neonates (birth to <28 days old), infants (28 days to ≤3 months), toddlers (>3 months to ≤2 years), children (>2 years to ≤11 years of age) and adolescents (>11 years to ≤17 years of age). Participants in each of the age groups will be randomized to one of 3 Zemuron doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 Sevoflurane at 2.0-2.5 minimum alveolar concentration (MAC) to up to 7%-8% inspired concentration in nitrous oxide at 0%-70%, or propofol 1-3 mg/kg (may be used in neonates only) for induction of anesthesia; isoflurane 1.0±0.2% expired end-tidal concentration in 0%-70% nitrous oxide and, if needed, propofol as intermittent bolus dose(s) (0.5-2 mg/kg) or infusion (50–150 μg/kg/min) for maintenance of anesthesia.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2004
    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
    United States: 196
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Germany: 8
    Worldwide total number of subjects
    207
    EEA total number of subjects
    11
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    18
    Infants and toddlers (28 days-23 months)
    77
    Children (2-11 years)
    55
    Adolescents (12-17 years)
    57
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 207 participants were enrolled and randomized in the trial; of these 189 received study drug. Allocation of participants to age groups “children” and “adolescent” in Trial Information versus other sections (including Disposition) differ slightly due to differences in age range definitions used (i.e., EudraCT versus protocol definitions).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    The assessor of the intubation conditions will be blinded to the study drug treatment, and will not be the person administering the study drug.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Zemuron 0.45 mg/kg – Neonates
    Arm description
    		 Neonate participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 0.6 mg/kg – Neonates
    Arm description
    		 Neonate participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 1.0 mg/kg – Neonates
    Arm description
    		 Neonate participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 0.45 mg/kg – Infants
    Arm description
    		 Infant participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 0.6 mg/kg – Infants
    Arm description
    		 Infant participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 1.0 mg/kg – Infants
    Arm description
    		 Infant participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 0.45 mg/kg – Toddlers
    Arm description
    		 Toddler participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 0.6 mg/kg – Toddlers
    Arm description
    		 Toddler participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 1.0 mg/kg – Toddlers
    Arm description
    		 Toddler participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 0.45 mg/kg – Children
    Arm description
    		 Child participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 0.6 mg/kg – Children
    Arm description
    		 Child participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 1.0 mg/kg – Children
    Arm description
    		 Child participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 0.45 mg/kg – Adolescents
    Arm description
    		 Adolescent participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 0.6 mg/kg – Adolescents
    Arm description
    		 Adolescent participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Arm title
    		 Zemuron 1.0 mg/kg – Adolescents
    Arm description
    		 Adolescent participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zemuron
    Investigational medicinal product code
    Other name
    Esmeron, rocuronium bromide, MK-8085, SCH 900085, Org 9426
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV bolus administered prior to intubation

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The assessor of the intubation conditions will be blinded to the study drug treatment, and will not be the person administering the study drug.
    Number of subjects in period 1
    		Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Started
    5
    7
    6
    9
    8
    5
    18
    20
    17
    17
    21
    17
    20
    17
    20
    Treated
    5
    7
    6
    9
    6
    5
    18
    16
    15
    16
    21
    16
    18
    16
    15
    Completed
    5
    7
    5
    8
    6
    5
    17
    16
    15
    15
    21
    16
    18
    16
    15
    Not completed
    0
    0
    1
    1
    2
    0
    1
    4
    2
    2
    0
    1
    2
    1
    5
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
         Inadvertently discontinued
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Surgery was complete
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Protocol deviation
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Not treated
    -
    -
    -
    -
    2
    -
    -
    4
    2
    1
    -
    1
    2
    1
    5

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Zemuron 0.45 mg/kg – Neonates
    Reporting group description
    		 Neonate participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Neonates
    Reporting group description
    		 Neonate participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Neonates
    Reporting group description
    		 Neonate participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Reporting group title
    Zemuron 0.45 mg/kg – Infants
    Reporting group description
    		 Infant participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Infants
    Reporting group description
    		 Infant participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Infants
    Reporting group description
    		 Infant participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Reporting group title
    Zemuron 0.45 mg/kg – Toddlers
    Reporting group description
    		 Toddler participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Toddlers
    Reporting group description
    		 Toddler participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Toddlers
    Reporting group description
    		 Toddler participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Reporting group title
    Zemuron 0.45 mg/kg – Children
    Reporting group description
    		 Child participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Children
    Reporting group description
    		 Child participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Children
    Reporting group description
    		 Child participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Reporting group title
    Zemuron 0.45 mg/kg – Adolescents
    Reporting group description
    		 Adolescent participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Adolescents
    Reporting group description
    		 Adolescent participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Adolescents
    Reporting group description
    		 Adolescent participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Reporting group values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents Total
    Number of subjects
    		 5 7 6 9 8 5 18 20 17 17 21 17 20 17 20 207
    Age Categorical
    Units: Subjects
        ≤18 years
    		 5 7 6 9 8 5 18 20 17 17 21 17 20 17 20 207
        Between 18 and 65 years
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        ≥65 years
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Gender Categorical
    Units: Subjects
        Female
    		 1 1 1 4 2 2 5 3 7 7 14 8 7 8 8 78
        Male
    		 4 6 5 5 6 3 13 17 10 10 7 9 13 9 12 129
    Subject analysis sets

    Subject analysis set title
    Zemuron 0.45 mg/kg – Neonates
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Neonate participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Neonates
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Neonate participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Neonates
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Neonate participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.45 mg/kg – Infants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Infant participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Infants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Infant participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Infants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Infant participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.45 mg/kg – Toddlers
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Toddler participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Toddlers
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Toddler participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Toddlers
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Toddler participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.45 mg/kg – Children
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Child participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Children
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Child participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Children
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Child participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.45 mg/kg – Adolescents
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Adolescent participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Adolescents
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Adolescent participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Adolescents
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Adolescent participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis sets values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Number of subjects
    5
    7
    6
    9
    6
    5
    18
    16
    15
    16
    21
    16
    18
    16
    15
    Age Categorical
    Units: Subjects
        ≤18 years
    5
    7
    6
    9
    6
    5
    18
    16
    15
    16
    21
    16
    18
    16
    15
        Between 18 and 65 years
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ≥65 years
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Age Continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender Categorical
    Units: Subjects
        Female
    1
    1
    1
    4
    0
    2
    5
    3
    6
    6
    14
    7
    7
    7
    7
        Male
    4
    6
    5
    5
    6
    3
    13
    13
    9
    10
    7
    9
    11
    9
    8

    End points

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    End points reporting groups
    Reporting group title
    Zemuron 0.45 mg/kg – Neonates
    Reporting group description
    		 Neonate participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Neonates
    Reporting group description
    		 Neonate participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Neonates
    Reporting group description
    		 Neonate participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Reporting group title
    Zemuron 0.45 mg/kg – Infants
    Reporting group description
    		 Infant participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Infants
    Reporting group description
    		 Infant participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Infants
    Reporting group description
    		 Infant participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Reporting group title
    Zemuron 0.45 mg/kg – Toddlers
    Reporting group description
    		 Toddler participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Toddlers
    Reporting group description
    		 Toddler participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Toddlers
    Reporting group description
    		 Toddler participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Reporting group title
    Zemuron 0.45 mg/kg – Children
    Reporting group description
    		 Child participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Children
    Reporting group description
    		 Child participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Children
    Reporting group description
    		 Child participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Reporting group title
    Zemuron 0.45 mg/kg – Adolescents
    Reporting group description
    		 Adolescent participants randomized to receive a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg – Adolescents
    Reporting group description
    		 Adolescent participants randomized to receive a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg – Adolescents
    Reporting group description
    		 Adolescent participants randomized to receive a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.45 mg/kg – Neonates
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Neonate participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Neonates
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Neonate participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Neonates
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Neonate participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.45 mg/kg – Infants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Infant participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Infants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Infant participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Infants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Infant participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.45 mg/kg – Toddlers
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Toddler participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Toddlers
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Toddler participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Toddlers
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Toddler participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.45 mg/kg – Children
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Child participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Children
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Child participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Children
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Child participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.45 mg/kg – Adolescents
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Adolescent participants who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Subject analysis set title
    Zemuron 0.6 mg/kg – Adolescents
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Adolescent participants who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Subject analysis set title
    Zemuron 1.0 mg/kg – Adolescents
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Adolescent participants who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Primary: Time from End of Zemuron Intubating Dose to Reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation)

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    End point title
    		 Time from End of Zemuron Intubating Dose to Reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation)
    End point description
    The duration from end of administration of the Zemuron intubating dose to reappearance of T3 was measured. Analysis population is the Per Protocol group, which is all participants who were randomized after protocol Amendment 2 (major revision to study), received study drug, had at least one efficacy parameter measured and did not have any major protocol violations. Also to be included, participant must have an evaluable assessment for this measure.
    End point type
    Primary
    End point timeframe
    From end of administration of Zemuron intubating dose to reappearance of T3
    End point values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Number of subjects analysed
    4
    6
    2
    8
    6
    3
    15
    14
    12
    12
    20
    14
    16
    16
    11
    Units: minutes
        arithmetic mean (standard deviation)
    49.53 ( 11.64 )
    55.68 ( 32.31 )
    114.43 ( 30.91 )
    46.44 ( 23.07 )
    62.34 ( 20.36 )
    116.48 ( 34.23 )
    35.30 ( 11.26 )
    41.77 ( 11.60 )
    76.07 ( 23.57 )
    23.55 ( 5.16 )
    38.27 ( 11.57 )
    53.46 ( 16.13 )
    36.96 ( 13.39 )
    41.78 ( 15.22 )
    61.56 ( 19.40 )
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way analysis of variance (ANOVA) model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 0.6 mg group
    Comparison groups
    Zemuron 0.6 mg/kg – Neonates v Zemuron 0.45 mg/kg – Neonates
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4692
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -19.711111
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -88.235806
         upper limit
    		 48.813584
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.45 mg/kg – Neonates v Zemuron 1.0 mg/kg – Neonates
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1598
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -73.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -192.38825
         upper limit
    		 44.988253
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.6 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.6 mg/kg – Neonates v Zemuron 1.0 mg/kg – Neonates
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3355
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -53.988889
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -191.03828
         upper limit
    		 83.060501
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 0.6 mg group
    Comparison groups
    Zemuron 0.45 mg/kg – Infants v Zemuron 0.6 mg/kg – Infants
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0927
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -23.45303
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.954875
         upper limit
    		 5.048814
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.45 mg/kg – Infants v Zemuron 1.0 mg/kg – Infants
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0127
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -55.906566
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -95.650489
         upper limit
    		 -16.162642
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.6 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.6 mg/kg – Infants v Zemuron 1.0 mg/kg – Infants
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1176
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -32.453535
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -75.469399
         upper limit
    		 10.562328
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 0.6 mg group
    Comparison groups
    Zemuron 0.45 mg/kg – Toddlers v Zemuron 0.6 mg/kg – Toddlers
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3246
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -5.936309
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.076657
         upper limit
    		 6.20404
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.45 mg/kg – Toddlers v Zemuron 1.0 mg/kg – Toddlers
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -42.382389
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.931093
         upper limit
    		 -29.833684
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.6 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.6 mg/kg – Toddlers v Zemuron 1.0 mg/kg – Toddlers
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -36.44608
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -49.165781
         upper limit
    		 -23.726379
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 0.6 mg group
    Comparison groups
    Zemuron 0.45 mg/kg – Children v Zemuron 0.6 mg/kg – Children
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0107
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -14.769785
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.850735
         upper limit
    		 -3.688836
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.45 mg/kg – Children v Zemuron 1.0 mg/kg – Children
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -31.746668
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.580508
         upper limit
    		 -19.912829
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.6 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.6 mg/kg – Children v Zemuron 1.0 mg/kg – Children
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0019
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -16.976883
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.169156
         upper limit
    		 -6.78461
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 0.6 mg group
    Comparison groups
    Zemuron 0.45 mg/kg – Adolescents v Zemuron 0.6 mg/kg – Adolescents
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.098
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -10.077731
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.128534
         upper limit
    		 1.973072
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.45 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.45 mg/kg – Adolescents v Zemuron 1.0 mg/kg – Adolescents
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0002
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -26.591007
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.145401
         upper limit
    		 -14.036614
    Statistical analysis title
    		 Treatment Comparison by Age Group
    Statistical analysis description
    Two-way ANOVA model including terms treatment group and site. Difference in least squares means is 0.6 mg/kg group minus 1.0 mg group
    Comparison groups
    Zemuron 0.6 mg/kg – Adolescents v Zemuron 1.0 mg/kg – Adolescents
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0104
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -16.513276
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.848623
         upper limit
    		 -4.177929

    Secondary: Time to Onset of Maximum Neuromuscular Block

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    End point title
    		 Time to Onset of Maximum Neuromuscular Block
    End point description
    The onset time, defined as the duration from end of administration of the Zemuron intubating dose to onset of maximum neuromuscular block, was measured. Onset of maximum neuromuscular block was identified as occurrence of the first T1 value (the first twitch of a TOF stimulation) which showed no further decline over three consecutive TOF stimulations following administration of the Zemuron intubating dose. Analysis population is the Per Protocol group, which is all participants who were randomized after protocol Amendment 2 (major revision to study), received study drug, had at least one efficacy parameter measured and did not have any major protocol violations. Also to be included, participant must have an evaluable assessment for this measure.
    End point type
    Secondary
    End point timeframe
    From end of administration of Zemuron intubating dose to onset of maximum neuromuscular block
    End point values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Number of subjects analysed
    4
    7
    4
    9
    6
    5
    16
    15
    14
    13
    20
    16
    17
    16
    13
    Units: minutes
        arithmetic mean (standard deviation)
    1.22 ( 0.67 )
    1.10 ( 0.67 )
    0.82 ( 0.67 )
    0.69 ( 0.35 )
    0.52 ( 0.21 )
    0.41 ( 0.19 )
    0.83 ( 0.47 )
    0.67 ( 0.30 )
    0.57 ( 0.32 )
    0.89 ( 0.42 )
    0.87 ( 0.33 )
    0.67 ( 0.21 )
    1.10 ( 0.38 )
    1.08 ( 0.47 )
    0.72 ( 0.17 )
    No statistical analyses for this end point

    Secondary: Maximum Neuromuscular Block

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    End point title
    		 Maximum Neuromuscular Block
    End point description
    Maximum neuromuscular block was defined as 100% minus the first T1 (expressed as percent of control) which showed no further decline over three consecutive TOF stimulations following administration of the Zemuron intubating dose. Analysis population is the Per Protocol group, which is all participants who were randomized after protocol Amendment 2 (major revision to study), received study drug, had at least one efficacy parameter measured and did not have any major protocol violations. Also to be included, participant must have an evaluable assessment for this measure.
    End point type
    Secondary
    End point timeframe
    At onset of maximum neuromuscular block, estimated to be up to approximately 2 minutes following administration of the Zemuron intubating dose
    End point values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Number of subjects analysed
    4
    7
    4
    9
    6
    5
    16
    15
    14
    13
    20
    16
    17
    16
    13
    Units: percent neuromuscular block
        arithmetic mean (standard deviation)
    98.75 ( 2.50 )
    97.86 ( 2.73 )
    100.00 ( 0.00 )
    100.00 ( 0.00 )
    99.50 ( 1.22 )
    100.00 ( 0.00 )
    100.00 ( 0.00 )
    100.00 ( 0.00 )
    100.00 ( 0.00 )
    100.00 ( 0.00 )
    100.00 ( 0.00 )
    100.00 ( 0.00 )
    100.00 ( 0.00 )
    99.69 ( 1.25 )
    100.00 ( 0.00 )
    No statistical analyses for this end point

    Secondary: Time from End of Zemuron Intubating Dose to Reappearance of T1

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    End point title
    		 Time from End of Zemuron Intubating Dose to Reappearance of T1
    End point description
    The duration from end of administration of the Zemuron intubating dose to reappearance of T1 was measured. Analysis population is the Per Protocol group, which is all participants who were randomized after protocol Amendment 2 (major revision to study), received study drug, had at least one efficacy parameter measured and did not have any major protocol violations. Also to be included, participant must have an evaluable assessment for this measure.
    End point type
    Secondary
    End point timeframe
    From end of administration of Zemuron intubating dose to reappearance of T1
    End point values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Number of subjects analysed
    4
    6
    4
    9
    6
    3
    16
    14
    12
    12
    20
    16
    16
    16
    13
    Units: minutes
        arithmetic mean (standard deviation)
    36.90 ( 12.25 )
    40.80 ( 23.70 )
    94.95 ( 22.85 )
    37.55 ( 19.97 )
    49.01 ( 14.01 )
    94.08 ( 16.54 )
    29.75 ( 10.05 )
    35.18 ( 9.94 )
    66.59 ( 22.48 )
    19.53 ( 4.51 )
    31.53 ( 9.33 )
    48.00 ( 14.70 )
    28.32 ( 11.69 )
    33.09 ( 12.93 )
    57.43 ( 23.19 )
    No statistical analyses for this end point

    Secondary: Time from End of Zemuron Intubating Dose to Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio to 0.7 (70%)

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    End point title
    		 Time from End of Zemuron Intubating Dose to Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio to 0.7 (70%)
    End point description
    The duration from end of administration of the Zemuron intubating dose to recovery of T4/T1 to 0.7 (70%) was measured. At complete recovery, the T4/T1 ratio is 1.0 (100%). Analysis population is the Per Protocol group, which is all participants who were randomized after protocol Amendment 2 (major revision to study), received study drug, had at least one efficacy parameter measured and did not have any major protocol violations. Also to be included, participant must have an evaluable assessment for this measure.
    End point type
    Secondary
    End point timeframe
    From end of administration of Zemuron intubating dose to T4/T1 ratio of 0.7 (70%)
    End point values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Number of subjects analysed
    2
    3
    1 [1]
    5
    5
    2
    12
    11
    9
    12
    18
    12
    14
    15
    8
    Units: minutes
        arithmetic mean (standard deviation)
    102.75 ( 30.88 )
    76.99 ( 28.56 )
    175.53 ( 0.0 )
    87.28 ( 20.08 )
    96.62 ( 22.08 )
    166.33 ( 57.66 )
    56.41 ( 23.17 )
    59.29 ( 16.39 )
    113.33 ( 18.04 )
    37.25 ( 10.81 )
    57.98 ( 23.22 )
    66.99 ( 17.27 )
    56.72 ( 21.05 )
    66.61 ( 20.36 )
    77.9 ( 27 )
    Notes
    [1] - For this arm, standard deviation (SD) of 0.0 indicates SD could not be calculated since N=1
    No statistical analyses for this end point

    Secondary: Time from End of Zemuron Intubating Dose to Recovery of T4/T1 Ratio to 0.8 (80%)

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    End point title
    		 Time from End of Zemuron Intubating Dose to Recovery of T4/T1 Ratio to 0.8 (80%)
    End point description
    The duration from end of administration of the Zemuron intubating dose to recovery of T4/T1 to 0.8 (80%) was measured. At complete recovery, the T4/T1 ratio is 1.0 (100%). Analysis population is the Per Protocol group, which is all participants who were randomized after protocol Amendment 2 (major revision to study), received study drug, had at least one efficacy parameter measured and did not have any major protocol violations. Also to be included, participant must have an evaluable assessment for this measure.
    End point type
    Secondary
    End point timeframe
    From end of administration of Zemuron intubating dose to T4/T1 ratio of 0.8 (80%)
    End point values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Number of subjects analysed
    2
    2
    1 [2]
    3
    5
    2
    11
    11
    9
    12
    17
    12
    14
    13
    9
    Units: minutes
        arithmetic mean (standard deviation)
    117.5 ( 42.54 )
    79.54 ( 11.16 )
    179.53 ( 0.0 )
    100.42 ( 15.37 )
    103.21 ( 25.01 )
    187.2 ( 50.42 )
    58.14 ( 22.97 )
    66.04 ( 19.76 )
    125.52 ( 19.13 )
    40.5 ( 11.87 )
    64.69 ( 24.19 )
    71.62 ( 19.41 )
    62.72 ( 27.69 )
    71.2 ( 23.82 )
    88.67 ( 30.09 )
    Notes
    [2] - For this arm, SD of 0.0 indicates SD could not be calculated since N=1
    No statistical analyses for this end point

    Secondary: Time from End of Zemuron Intubating Dose to Recovery of T4/T1 Ratio to 0.9 (90%)

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    End point title
    		 Time from End of Zemuron Intubating Dose to Recovery of T4/T1 Ratio to 0.9 (90%)
    End point description
    The duration from end of administration of the Zemuron intubating dose to recovery of T4/T1 to 0.9 (90%) was measured. At complete recovery, the T4/T1 ratio is 1.0 (100%). Analysis population is the Per Protocol group, which is all participants who were randomized after protocol Amendment 2 (major revision to study), received study drug, had at least one efficacy parameter measured and did not have any major protocol violations. Also to be included, participant must have an evaluable assessment for this measure.
    End point type
    Secondary
    End point timeframe
    From end of administration of Zemuron intubating dose to T4/T1 ratio of 0.9 (90%)
    End point values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Number of subjects analysed
    2
    2
    1 [3]
    3
    4
    1 [4]
    9
    10
    7
    12
    13
    9
    10
    11
    7
    Units: minutes
        arithmetic mean (standard deviation)
    133.99 ( 59.5 )
    119.61 ( 42.72 )
    180.78 ( 0.0 )
    108.58 ( 4.69 )
    111.18 ( 30.56 )
    255.58 ( 0.0 )
    65.13 ( 31.28 )
    68.13 ( 19.9 )
    148.76 ( 22.15 )
    46.53 ( 15.2 )
    71.04 ( 28.95 )
    76.03 ( 26.81 )
    63.5 ( 31.97 )
    73.42 ( 24.75 )
    97.74 ( 34.42 )
    Notes
    [3] - For this arm, SD of 0.0 indicates SD could not be calculated since N=1
    [4] - For this arm, SD of 0.0 indicates SD could not be calculated since N=1
    No statistical analyses for this end point

    Secondary: Intubation Score for Participants who had Successful First Attempt Intubations within 75 Seconds after Administration of Zemuron

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    End point title
    		 Intubation Score for Participants who had Successful First Attempt Intubations within 75 Seconds after Administration of Zemuron
    End point description
    Intubation conditions were scored using 3-point scales as described by Viby-Mogensen et al (Acta Anaesthesiol Scand 1996;40:59-74): laryngoscopy (single item rated easy, fair or difficult), vocal cords (“position” rated abducted, intermediate or closed; “movement” rated none, moving or closing) and reaction to intubation (“movement of the limbs” rated none, slight or vigorous; “airway reactivity” rated none, diaphragm or sustained >10 seconds). The first, second and third rating levels were equated to scores of excellent, good and poor, respectively. Overall intubation condition was rated “excellent” if all 5 items were rated excellent, “good” if all were rated good or excellent, and “poor” if any was rated poor. Overall excellent/good rating was considered “clinically acceptable”; overall poor rating was “unacceptable.” Analysis population is Per Protocol group. Also to be included, participant must have had successful first attempt intubation within 75 seconds after Zemuron dose.
    End point type
    Secondary
    End point timeframe
    Up to 75 seconds after administration of Zemuron
    End point values
    		 Zemuron 0.45 mg/kg – Neonates Zemuron 0.6 mg/kg – Neonates Zemuron 1.0 mg/kg – Neonates Zemuron 0.45 mg/kg – Infants Zemuron 0.6 mg/kg – Infants Zemuron 1.0 mg/kg – Infants Zemuron 0.45 mg/kg – Toddlers Zemuron 0.6 mg/kg – Toddlers Zemuron 1.0 mg/kg – Toddlers Zemuron 0.45 mg/kg – Children Zemuron 0.6 mg/kg – Children Zemuron 1.0 mg/kg – Children Zemuron 0.45 mg/kg – Adolescents Zemuron 0.6 mg/kg – Adolescents Zemuron 1.0 mg/kg – Adolescents
    Number of subjects analysed
    3
    4
    3
    9
    4
    4
    11
    11
    13
    11
    18
    13
    14
    13
    10
    Units: participants
        Acceptable – Excellent
    1
    3
    2
    6
    2
    3
    5
    9
    9
    9
    15
    9
    9
    9
    8
        Acceptable – Good
    2
    1
    1
    3
    1
    0
    5
    1
    4
    2
    3
    3
    5
    4
    2
        Unacceptable – Poor
    0
    0
    0
    0
    1
    1
    1
    1
    0
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For non-serious adverse events (AEs), through in-trial period, which ends at stable neuromuscular recovery or administration of another muscle relaxant or a reversal agent, whichever occurs first. For serious AEs, up to 7 days post-surgery
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Zemuron 0.45 mg/kg
    Reporting group description
    		 Participants in all age groups combined who received a single IV bolus intubation dose of 0.45 mg/kg Zemuron

    Reporting group title
    Zemuron 0.6 mg/kg
    Reporting group description
    		 Participants in all age groups combined who received a single IV bolus intubation dose of 0.6 mg/kg Zemuron

    Reporting group title
    Zemuron 1.0 mg/kg
    Reporting group description
    		 Participants in all age groups combined who received a single IV bolus intubation dose of 1.0 mg/kg Zemuron

    Serious adverse events
    		 Zemuron 0.45 mg/kg Zemuron 0.6 mg/kg Zemuron 1.0 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 66 (6.06%)
    3 / 66 (4.55%)
    0 / 57 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Ventricular septal defect
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Lymphocele
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 66 (1.52%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular block, complete
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrospinal fistula
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 66 (1.52%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 66 (1.52%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 66 (1.52%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Escherichia sepsis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 66 (1.52%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incision site abscess
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 66 (1.52%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 66 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Zemuron 0.45 mg/kg Zemuron 0.6 mg/kg Zemuron 1.0 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 66 (18.18%)
    14 / 66 (21.21%)
    16 / 57 (28.07%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    9 / 66 (13.64%)
    11 / 66 (16.67%)
    10 / 57 (17.54%)
         occurrences all number
    9
    11
    10
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    4 / 66 (6.06%)
    5 / 66 (7.58%)
    7 / 57 (12.28%)
         occurrences all number
    4
    5
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Dec 2004
    Amendment 01: Primary reason for amendment was to update list of investigators/trial centers.
    15 Sep 2005
    Amendment 02: Primary reason for amendment was to exclude use of IV lidocaine and glycopyrrolate, define use of fentanyl for induction/maintenance of anesthesia, redefine the age groups for study participants, permit direct measurements of ventilatory parameters, include measurement of central body temperature, revise directions for induction with sevoflurane and description of boundary conditions for arterial oxygen percent saturation (SAO2) and end-tidal carbon dioxide (ETCO2), clarify description of reduction of sevoflurane after intubation, revise the blood sampling schedules and include reporting of Medical Device Reporting (MDR) reportable events.
    07 Dec 2005
    Amendment 03: Primary reason for amendment was to define use of local anesthetics for premedication and during surgery, define duration of induction of anesthesia, revise directions for administration of Zemuron for intubation, revise directions for measuring ventilatory parameters, revise the description of boundary conditions for SAO2 and include a requirement for obtaining acceptable practice neuromuscular recordings before neuromuscular transmission evaluation.
    20 Jan 2006
    Amendment 04: Primary reason for amendment was to indicate that non-United States (non-US) sites would not be conducting the trial under the US Investigational New Drug (IND) authorization, include assessment of appropriateness to initiate laryngoscopy at 60 seconds after administration of Zemuron, specify criteria for vital signs and electrocardiogram (ECG) findings that are considered to be adverse events, specify that any signs of histamine release should be captured as adverse events, clarify procedures for blinding assessor of intubation conditions and revise criteria for clinically significant abnormal values for cardiovascular parameters.
    28 Sep 2006
    Amendment 05: Primary reason for amendment was to add the use of epidural/caudal anesthesia to general anesthesia.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    15 Jun 2005
    The P05798 protocol was performed under a US Food and Drug Administration (FDA) Pediatric Written Request (PWR). The protocol was amended several times in response to PWR amendments, FDA’s comments on the protocol, changing FDA directives regarding the collection of data in clinical trials (e.g., FDA directive for collecting ethnicity data) or in response to requests from the trial site Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs). The major revisions to the protocol introduced in Protocol Amendments 2, 3 and 4 substantially altered trial conditions and assessment parameters. The trial was temporarily suspended during this period, and re-initiated after Protocol Amendment 4.
    15 Mar 2006

    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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