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-AT
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-13
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• 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

Exclusion Criteria

• 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 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