A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia
A Randomized, Assessor-blind, Dose-ranging, Phase IIIB, Multicenter Trial Comparing the Intubating Conditions and Time Course of Block of Three Different Intubating Doses (0.45 mg/kg, 0.6 mg/kg, and 1.0 mg/kg) of Zemuron® in Pediatric and Adolescent Subjects Under General Anesthesia
2 other identifiers
interventional
207
0 countries
N/A
Brief Summary
The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) 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). Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2004
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 26, 2005
CompletedFirst Posted
Study publicly available on registry
July 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJune 1, 2015
May 1, 2015
2.6 years
July 26, 2005
May 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation)
during surgery
Secondary Outcomes (1)
Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score
during and after surgery
Study Arms (3)
0.45 mg/kg Zemuron
EXPERIMENTAL0.45 mg/kg Zemuron
0.6 mg/kg Zemuron
ACTIVE COMPARATOR0.6 mg/kg Zemuron
1.0 mg/kg Zemuron
EXPERIMENTAL1.0 mg/kg Zemuron
Interventions
A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
Eligibility Criteria
You may qualify if:
- Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia.
You may not qualify if:
- 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 trial will not be allowed to enter.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tirotta CF, Brandom B, Siddiqui MS, Ehlers M, Betzel J, Chen J-Y, De Bie J, Blobner M. Time Course of Rocuronium-Induced Neuromuscular Blockade in Pediatric Patients: A Phase III, Randomized, Dose-Response Study. J Anesthe Clin Res. 2012;3:189.
RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2005
First Posted
July 28, 2005
Study Start
December 1, 2004
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
June 1, 2015
Record last verified: 2015-05