A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia
Completed
Merck Sharp & Dohme Corp.
Phase 3
2004-12-01
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.
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Completed
Merck Sharp & Dohme Corp.
Phase 3
2004-10-01
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).
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
Completed
Merck Sharp & Dohme Corp.
Phase 3
2005-05-30
The purpose of this study is:
- to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616)
given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in
pediatric and adult participants
- to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants,
and to evaluate the safety of sugammadex in pediatric and adult participants.
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