A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)
Condition: Anesthesia, General
Intervention: sugammadex; Placebo
Intervention description: After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.; After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of placebo IV was administered
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of this trial was to establish the dose-response of T2 (the amplitude of the
      first response of second twitch to train of four (TOF) stimulation, expressed as percentage
      of control first twitch,T1) in Japanese and Caucasian participants. Part A: Japanese
      Participants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is of American Society of Anesthesiologists (ASA) class 1 - 3;

          -  Is at least 20 years but under 65 years of age;

          -  Japanese participants;

          -  Is scheduled for elective surgery in supine position and under sevoflurane anesthesia,
             in need of administration of neuromuscular blocking agents (NMBAs), with an
             anticipated duration of about 1.5-3 hours;

          -  Has given written informed consent.

        Exclusion Criteria:

          -  Participants in whom a difficult intubation because of anatomical malformations was
             expected;

          -  Is known or suspected to have neuromuscular disorders impairing the effect of NMBAs
             and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl)
             and/or severe hepatic dysfunction.

          -  Is known or suspected to have a (family) history of malignant hyperthermia;

          -  Is known or suspected to have an allergy to narcotics, muscle relaxants or other
             medication used during general anesthesia;

          -  Is receiving medication expected to interfere with the rocuronium or vecuronium given
             in this trial, based on the dose and time of administration;

          -  Females who were pregnant;

          -  Females not using birth control or using only oral contraception as birth control
             continuously;

          -  Were breast-feeding;

          -  Has already participated in P05956, or in another trial with sugammadex;

          -  Has participated in another clinical trial within 6 months of entering into P05956