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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 149
- Primary Endpoint
- Total Dose of Zemuron (Rocuronium) Administered
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Rocuronium bolus maintenance
Rocuronium bolus maintenance
Intervention: Rocuronium bolus maintenance (Drug)
Rocuronium continuous infusion maintenance
Rocuronium continuous infusion maintenance
Intervention: rocuronium continuous infusion maintenance (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%(after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium))
- Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%(after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium))
- Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%(after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium))