Dose-Finding Pediatric Trial With Sugammadex (19.4.306)(P05961)(COMPLETED)

• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7 [ Time Frame: after surgery ] [ Designated as safety issue: No ]
• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8. [ Time Frame: after surgery ] [ Designated as safety issue: No ]

• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7
• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8.

The purpose of this study is:

• to explore the dose-response relation of sugammadex given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult subjects
• to explore the pharmacokinetics of sugammadex in pediatric and adult subjects, and to evaluate the safety of sugammadex in pediatric and adult subjects.

• Drug: Sugammadex 0.5 mg/kg
  Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of 0.5 mg/kg sugammadex will be given.
  Other Name: Org 25969
• Drug: Sugammadex 1.0 mg/kg
  Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of 1.0 mg/kg sugammadex will be given.
  Other Name: Org 25969
• Drug: Sugammadex 2.0 mg/kg
  Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of 2.0 mg/kg sugammadex will be given.
  Other Name: Org 25969
• Drug: Sugammadex 4.0 mg/kg
  Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of 4.0 mg/kg sugammadex will be given.
  Other Name: Org 25969
• Drug: Placebo
  Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of placebo will be given.

• Experimental: Arm 1
  Sugammadex 0.5 mg/kg
  Intervention: Drug: Sugammadex 0.5 mg/kg
• Experimental: Arm 2
  Sugammadex 1.0 mg/kg
  Intervention: Drug: Sugammadex 1.0 mg/kg
• Experimental: Arm 3
  Sugammadex 2.0 mg/kg
  Intervention: Drug: Sugammadex 2.0 mg/kg
• Experimental: Arm 4
  Sugammadex 4.0 mg/kg
  Intervention: Drug: Sugammadex 4.0 mg/kg
• Placebo Comparator: Arm 5
  Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• ASA class 1 - 2, between the ages of 28 days and 65 years inclusive, and between the ages of 2 and 65 years inclusive for Germany and between the ages of 6 and 65 years inclusive for Finland
• Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium
• Scheduled for surgical procedures in the supine position
• Subjects who, and/or whose parent(s) or legal guardian(s) have given written informed consent [or appropriate assent, if applicable]

Exclusion Criteria:

• Known or suspected neuromuscular disorders impairing NMB and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges
• Known or suspected to have a (family) history of malignant hyperthermia
• Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
• Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration
• Pregnancy
• Childbearing potential not using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), IUD, abstinence
• Breast -feeding
• Prior participation in trial 19.4.306
• Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into trial 19.4.306