A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia.
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 trial will not be allowed to enter.
Trial design
Primary purpose
Allocation
Interventional model
Masking
207 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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