A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of 4.0 mg.kg-1 sugammadex administered at 1-2 PTC in subjects with normal or severely impaired renal function

Organon Nederland BV0 个研究点目标入组 70 人开始时间: 2008年5月29日最近更新: 2012年3月19日

研究概览

暂无简介。

•At least 18 years of age
•ASA class 1-3
•Creatinine clearance (CLcr) < 30 mL/min and no anticipated clinical indication for high flux hemodialysis during first 24 hours after sugammadex administration (for renally impaired group) or CLcr = 80 mL/min (for controlgroup)
•Scheduled for a surgical procedure under general anesthesia with propofol requiring neuromuscular relaxation with the use of rocuronium
•Scheduled for a surgical procedure in supine position
•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 known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction
•Subjects scheduled for renal transplant surgery
•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 NMBAs, such as antibiotics, anticonvulsants and Mg2+
•Subjects who have already participated in a sugammadex trial
•Subjects who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into 19.4.328
•Female subjects who are pregnant*
•Female subjects who are breast-feeding
•* In female subjects pregnancy will be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.

发起方

Organon Nederland BV