An open-label, randomized, phase IIIB, multicenter trial to evaluate the pharmacodynamic parameters of intubation bolus, and bolus and infusion maintenance doses of Zemuron® in pediatric and adolescent subjects

• Conditions: ot applicable

• Registration Number: EUCTR2005-002926-67-DE
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-23
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Males or non-pregnant (determined by urine or serum HCG test), non-nursing females from birth to =<17 years of age; and
•Subjects of ASA Class 1, 2, or 3 scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified