None listed
Conditions
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Males or non-pregnant (determined by urine or serum HCG test), non-nursing females from birth to ==65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Subjects > 17 years of age or preterm neonates (< 37 weeks gestational age at birth); •Subjects with congenital anomalies or airway obstructions that would preclude visualization or intubation of the trachea; •Subjects with known significant renal or hepatic disorders determined by medical history, physical examination, or laboratory tests; •Subjects known or suspected of having neuromuscular disorders; •Subjects known or suspected of having personal or family history of malignant hyperthermia; •Subjects known or suspected of having allergy to narcotic analgesics, hypnotics, neuromuscular blocking agents, or other medications used during general anesthesia; •Subjects who are receiving medications (systemic corticosteroids, anticonvulsants, aminoglycosides, macrolides or polypeptide antibiotic) during the pre-trial period or who will be receiving medications (systemic corticosteroids, anticonvulsants, aminoglycosides, macrolides or polypeptide antibiotic) during the in-trial period in a dose regimen known to modify the action of neuromuscular blocking agents; •Subjects who would require the use of pneumatic tourniquet during the surgical procedure; •Subjects participating as research subjects in another clinical trial not pre-approved by Organon within 30 days before this trial; •Subjects who have already participated in this trial; or •Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, the subject has not given appropriate assent to participate in accordance with the ethical principles that have their origin in the Declaration of Helsinki, the ICH Guideline for Good Clinical Practice, and applicable regulatory requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the dose requirements of Zemuron®, when administered as a bolus dose for intubation and when administered by either continuous infusion or bolus doses for maintenance in term neonates (birth to 3 months to = 2 to = 11 to =<17 years of age).;Secondary Objective: 1.To evaluate the spontaneous recovery time to 70%, 80%, and 90% of T4/T1 ratio from the reappearance of T3 after the termination of Zemuron infusion or after the last maintenance bolus dose in term neonates, infants, toddlers, children, and adolescent subjects. 2.To determine the onset times of a bolus intubating dose of Zemuron in term neonates, infants, toddlers, children, and adolescent subjects. 3.To collect sparse samples for population pharmacokinetic analysis. 4.To evaluate safety data of intubation and maintenance doses of Zemuron. ;Primary end point(s): The total dose from administration of intubating dose to reappearance of T3 after the last maintenance bolus dose of Zemuron, or discontinuation of Zemuron infusion. | — |
Countries
Germany
Outcome results
None listed