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

NCT00124722 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2015-06-01

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia

Interventions

DRUG

Rocuronium bromide (Zemuron)

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

DRUG

Rocuronium bromide (Zemuron)

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

DRUG

Rocuronium bromide (Zemuron)

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-07-31
Completion
2007-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00124722 on ClinicalTrials.gov