A multi-center, randomized, parallel group, comparative, active controlled, safety-assessor blinded, phase IIIa, pivotal trial, in adult subjects comparing Org 25969 with neostigmine as reversal agent of a neuromuscular block induced by rocuronium or vecuronium at reappearance of T2. - Aurora
- Conditions
- ot applicable
- Registration Number
- EUCTR2005-001135-30-GB
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 196
• Subjects of ASA class 1 to 4, above or equal to the age of 18 years;
• Subjects scheduled for surgical procedure with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
• Subjects scheduled for surgical procedures in supine position;
• Subjects who have given written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Subjects in whom a difficult intubation because of anatomical malformations is expected;
• Subjects known or suspected to have neuromuscular disorders impairing NMB and/or significant renal dysfunction;
• Subjects known or suspected to have a (family) history of malignant hyperthermia;
• Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
• Subjects receiving medication in a dose and/or at a time point known to interfere with NMBA, such as antibiotics, anticonvulsants and Mg2+;
• Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
• Subjects who have already participated in an Org 25969 trial;
• Subjects who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.301;
• Female subjects who are pregnant;
• Female subjects of childbearing potential not using any method of birth control or using only hormonal contraception as birth control;
• Female subjects who are breast-feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method