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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00124722
First received: July 26, 2005
Last updated: May 29, 2015
Last verified: May 2015

July 26, 2005
May 29, 2015
December 2004
July 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00124722 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia
  • Drug: Rocuronium bromide (Zemuron)
    A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
    Other Names:
    • ORG 9426
    • SCH 900085
    • Zemuron
  • Drug: Rocuronium bromide (Zemuron)
    A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation.
    Other Names:
    • ORG 9426
    • SCH 900085
    • Zemuron
  • Drug: Rocuronium bromide (Zemuron)
    A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation.
    Other Name: ORG 9426, SCH 900085, Zemuron
  • Experimental: 0.45 mg/kg Zemuron
    0.45 mg/kg Zemuron
    Intervention: Drug: Rocuronium bromide (Zemuron)
  • Active Comparator: 0.6 mg/kg Zemuron
    0.6 mg/kg Zemuron
    Intervention: Drug: Rocuronium bromide (Zemuron)
  • Experimental: 1.0 mg/kg Zemuron
    1.0 mg/kg Zemuron
    Intervention: Drug: Rocuronium bromide (Zemuron)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
July 2007
July 2007   (final data collection date for primary outcome measure)

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.
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00124722
P05798, 021049
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP