A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of 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) and toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (>11 years to less than or equal to 17 years of age). Subjects 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.

Official Title
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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

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Rocuronium bromide (Zemuron)
* Drug: Rocuronium bromide (Zemuron)
* Drug: Rocuronium bromide (Zemuron)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia. Exclusion Criteria: Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trial will not be allowed to enter.

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.45 mg/kg Zemuron<br>0.45 mg/kg Zemuron | Drug: Rocuronium bromide (Zemuron)<br>* A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.<br>* Other names: Zemuron;|
| Active Comparator: 0.6 mg/kg Zemuron<br>0.6 mg/kg Zemuron | Drug: Rocuronium bromide (Zemuron)<br>* A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.<br>* Other names: Zemuron;|
| Experimental: 1.0 mg/kg Zemuron<br>1.0 mg/kg Zemuron | Drug: Rocuronium bromide (Zemuron)<br>* A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.<br>* Other names: ORG 9426, SCH 900085, Zemuron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation) |  | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score |  | during and after surgery |