Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)

A Multicenter, Randomized, Parallel Group, Comparative, Safety-Assessor Blinded, Phase IIIa Trial in Adult Surgical Subjects Under General Anesthesia at Increased Risk for Pulmonary Complications

The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) Class 1 to 3;
• Has been diagnosed with or having a past history of pulmonary disease;
• Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;
• Is scheduled for surgery in supine position;
• Has given written informed consent;

Exclusion Criteria:

• Is expected to have a difficult intubation due to anatomical malformations;
• Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
• Has known or suspected of having a (family) history of malignant hyperthermia;
• Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery;
• Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
• Is a female who is pregnant or breast-feeding;
• Is a female of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence] or using only hormonal contraception as birth control;
• Has already participated in a sugammadex trial including Protocol 19.4.308;
• Has participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.