Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)

A Multicenter, Parallel Group, Comparative, Phase IIIa Trial to Compare the Efficacy, Safety, and Pharmacokinetics of Org 25969 in Elderly Subjects With Adult Subjects

The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) Class 1 to 3
• 18 years of age or older
• Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium
• Scheduled for surgery in supine position
• Given written informed consent

Exclusion Criteria:

• Participants in whom a difficult intubation is expected due to anatomical malformations
• Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction
• Participants known or suspected to have a (family) history of malignant hyperthermia
• Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medications used during surgery
• Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and magnesium
• Female participants who are pregnant or breast-feeding
• Females participants of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), intrauterine device (IUD), abstinence]
• Participants who had already participated in a Org 25969 trial including Protocol 19.4.305
• Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.305