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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124722
First Posted: July 28, 2005
Last Update Posted: June 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
July 26, 2005
July 28, 2005
June 1, 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 ]
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 ]
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Parallel Assignment
Masking: None (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.
Sexes Eligible for Study: All
up to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00124722
P05798
021049
No
Not Provided
Not Provided
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