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

May 29, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0.45 mg/kg Zemuron
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
Other Names:
  • Zemuron
  • SCH 900085
  • ORG 9426
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.
Other Names:
  • Zemuron
  • SCH 900085
  • ORG 9426
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.
Other Names:
  • ORG 9426, SCH 900085, Zemuron
ACTIVE_COMPARATOR: 0.6 mg/kg Zemuron
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
Other Names:
  • Zemuron
  • SCH 900085
  • ORG 9426
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.
Other Names:
  • Zemuron
  • SCH 900085
  • ORG 9426
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.
Other Names:
  • ORG 9426, SCH 900085, Zemuron
EXPERIMENTAL: 1.0 mg/kg Zemuron
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
Other Names:
  • Zemuron
  • SCH 900085
  • ORG 9426
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.
Other Names:
  • Zemuron
  • SCH 900085
  • ORG 9426
Drug: Rocuronium bromide (Zemuron)
A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.
Other Names:
  • ORG 9426, SCH 900085, Zemuron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
during and after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Tirotta CF, Brandom B, Siddiqui MS, Ehlers M, Betzel J, Chen J-Y, De Bie J, Blobner M. Time Course of Rocuronium-Induced Neuromuscular Blockade in Pediatric Patients: A Phase III, Randomized, Dose-Response Study. J Anesthe Clin Res. 2012;3:189.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

July 26, 2005

First Submitted That Met QC Criteria

July 26, 2005

First Posted (ESTIMATE)

July 28, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05798
  • 021049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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