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

V Organon0 个研究点目标入组 196 人开始时间: 2005年10月6日最近更新: 2012年4月18日

适应症

试验速览

暂无简介。

•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.

发起方

V Organon