Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)

Comparison of Rocuronium and Org25969 With Cisatracurium and Neostigmine When Neuromuscular Block is Reversed at Reappearance of T2

The purpose of this study was to demonstrate in adult patients a faster recovery from a neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50 ug/kg neostigmine after cisatracurium when administered at reappearance of T2

Inclusion Criteria:

• Subjects of ASA 1 - 4;
• Subjects above or equal to the age of 18;
• Scheduled for surgical procedures with a general anesthesia requiring neuromuscular relaxation with the use of rocuronium or cisatracurium;
• Scheduled for surgical procedures in supine position;
• Given written informed consent.

Exclusion Criteria:

• Subjects in whom a difficult intubation because of anatomical malformations was expected;
• Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (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 neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
• Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
• Subjects who had already participated in an Org25969 trial;
• Subjects who had participated in another clinical trial (not pre-approved by NV Organon) within 30 days of entering into CT 19.4.310.
• Female subjects who are pregnant:
• Female subjects of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
• Female subjects who were breast -feeding.