A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron�) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia
Intervention: Rocuronium bolus maintenance (Drug); rocuronium continuous infusion maintenance (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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).
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Total Dose of Zemuron (Rocuronium) Administered
Secondary outcome: Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80% Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%
Eligibility
Minimum age: N/A.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: October 2004
Last updated: February 13, 2015
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