At a glance
ClinicalIndex Comparison Record- ✓Age: birth to 17 years
- ✓Scheduled for surgery with anticipated anesthesia duration of approximately 2 hours or more
- ✓Requires maintenance muscle relaxation dosing during the procedure
- ✕Lack of parental/legal guardian written consent or subject assent (when applicable)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Rocuronium bolus maintenance and rocuronium continuous infusion maintenance for Anesthesia. Completed, enrolled 149 participants.
Detailed 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 Details
Timeline
Interventions
Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation