Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
Condition: Anesthesia
Intervention: Sugammadex 0.5 mg/kg; Sugammadex 1 mg/kg; Sugammadex 2 mg/kg; Sugammadex 4 mg/kg; Placebo; Rocuronium bromide
Intervention description: IV infusion; IV infusion; IV infusion; IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Bromides; Rocuronium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 94.0
Sex: All
Minimum age: 28 Days
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is:

        -  to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616)
           given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in
           pediatric and adult participants

        -  to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants,
           and to evaluate the safety of sugammadex in pediatric and adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (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 rocuronium

          -  Scheduled for surgical procedures in the supine position

          -  Participants 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 neuromuscular blockade (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), intrauterine device
             (IUD), abstinence

          -  Breast-feeding

          -  Prior participation in any study with Org 25969 (sugammadex)

          -  Participation in another clinical trial, not pre-approved by NV Organon, within 30
             days of entering into study 19.4.306 (MK-8616-034, P05961)