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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-07-31

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.

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Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.45 mg/kg Zemuron

Group Type EXPERIMENTAL

Rocuronium bromide (Zemuron)

Intervention Type DRUG

A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.

0.6 mg/kg Zemuron

Group Type ACTIVE_COMPARATOR

Rocuronium bromide (Zemuron)

Intervention Type DRUG

A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.

1.0 mg/kg Zemuron

Group Type EXPERIMENTAL

Rocuronium bromide (Zemuron)

Intervention Type DRUG

A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.

Interventions

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Rocuronium bromide (Zemuron)

A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.

Intervention Type DRUG

Rocuronium bromide (Zemuron)

A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.

Intervention Type DRUG

Rocuronium bromide (Zemuron)

A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.

Intervention Type DRUG

Other Intervention Names

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ORG 9426 SCH 900085 Zemuron ORG 9426 SCH 900085 Zemuron ORG 9426, SCH 900085, Zemuron

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.

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No