Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)

• Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.7 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
• Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.8 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]

The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects for registration purposes in China.

• Anesthesia, General
• Neuromuscular Blockade

• Drug: Sugammadex
  After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered.
  Other Name: Org 25969, Bridion®
• Drug: neostigmine
  After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
  Other Name: Neostigmine with atropine

• Experimental: Sugammadex in Caucasian Subjects
  At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
  Intervention: Drug: Sugammadex
• Active Comparator: Neostigmine in Caucasian Subjects
  At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
  Intervention: Drug: neostigmine
• Experimental: Sugammadex in Chinese Subjects
  At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
  Intervention: Drug: Sugammadex
• Active Comparator: Neostigmine in Chinese Subjects
  At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
  Intervention: Drug: neostigmine

Inclusion Criteria:

-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).

For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.

Exclusion Criteria:

-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the (family of) study/sponsor staff.