A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
Condition: Anesthesia, General
Intervention: Sugammadex; Placebo; Rocuronium; Vecuronium
Intervention description: After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) 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 0.02-0.03 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 (arm 1) or 0.1 mg/kg vecuronium (arm 6).
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of Placebo IV was administered; After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary.; After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
Intervention MeSH terms: Rocuronium; Vecuronium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of the trial was to establish the dose-response relation of sugammadex (Org
      25969) given as a reversal agent of rocuronium or vecuronium at reappearance 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) during sevoflurane anesthesia for
      Caucasian 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;

          -  Caucasian participants;

          -  Is scheduled for elective surgery requiring muscle relaxation in supine position and
             under sevoflurane anesthesia 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 neuromuscular blocking
             (NMB) 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 of childbearing potential not using birth control or using only oral
             contraception as birth control;

          -  Was breast-feeding;

          -  Has already participated in P05971, or in another trial with sugammadex;

          -  Has participated in another clinical trial, not preapproved by the Sponsor, within 6
             months of entering into P05971.