Phase 3
Completed N=149
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Anesthesia
Source: ClinicalTrials.gov NCT00124735 ↗
Enrolled (actual)
149
Serious AEs
0.7%
Results posted
Apr 2009
Primary outcomePrimary: Total Dose of Zemuron (Rocuronium) Administered — 0.91; 0.78; 0.86; 0.81 mg/kg
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 3 months to 11 years to less than or equal to 17 years of age).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Dose of Zemuron (Rocuronium) Administered |
0.91; 0.78; 0.86; 0.81; 0.96; 1.01 | — |
| SECONDARY Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70% |
29.62; 33.25; 22.65; 16.19; 28.04; 43.32 | — |
| SECONDARY Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80% |
36.62; 43.58; 32.39; 20.43; 35.75; 57.83 | — |
| SECONDARY Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90% |
28.25; 53.66; 45.31; 23.09; 49.25; 52.25 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00124735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.