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Completed

NCT Number: NCT00124722

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

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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Key information

Conditions

Anesthesia

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rocuronium bromide (Zemuron)

Drug

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

Other names: ORG 9426, SCH 900085, Zemuron

Primary outcomes

  1. Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation)

    Time frame: during surgery

Secondary outcomes

  1. Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score

    Time frame: during and after surgery

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 28, 2005
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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