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A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)

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ClinicalTrials.gov Identifier: NCT00124735
Recruitment Status : Completed
First Posted : July 28, 2005
Results First Posted : April 15, 2009
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE July 26, 2005
First Posted Date  ICMJE July 28, 2005
Results First Submitted Date  ICMJE December 5, 2008
Results First Posted Date  ICMJE April 15, 2009
Last Update Posted Date August 24, 2016
Study Start Date  ICMJE October 2004
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
Total Dose of Zemuron (Rocuronium) Administered [ Time Frame: during surgery ]
Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol [PP] data set)
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2009)
  • Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70% [ Time Frame: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) ]
    The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
  • Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80% [ Time Frame: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) ]
    The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
  • Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90% [ Time Frame: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) ]
    The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Official Title  ICMJE An Open-label, Randomized, Phase IIIB, Multicenter Trial to Evaluate the Pharmacodynamic Parameters of Intubation Bolus, and Bolus and Infusion Maintenance Doses of Zemuron® in Pediatric and Adolescent Subjects
Brief Summary The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Drug: Rocuronium bolus maintenance
    Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
    Other Names:
    • Zemuron
    • ORG 9426
  • Drug: rocuronium continuous infusion maintenance
    Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
    Other Names:
    • Zemuron
    • ORG 9426
Study Arms  ICMJE
  • Experimental: Rocuronium bolus maintenance
    Rocuronium bolus maintenance
    Intervention: Drug: Rocuronium bolus maintenance
  • Experimental: Rocuronium continuous infusion maintenance
    Rocuronium continuous infusion maintenance
    Intervention: Drug: rocuronium continuous infusion maintenance
Publications * Bhattacharya ST, Jeffrey Koh J, Martin L, Suresh S, Frietsch T. Randomized, Multicenter Trial of Rocuronium in Neonates, Infants, Toddlers, Children & Adolescents [abstract]. Anesthesiology. 2009;111(5):A841.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2007)
149
Original Enrollment  ICMJE
 (submitted: July 26, 2005)
120
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects from birth up to 17 years of age who are scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).

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 trials will not be allowed to enter.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00124735
Other Study ID Numbers  ICMJE P05797
21048
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date June 2016

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