A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957)
Condition: Anesthesia, General
Intervention: Sugammadex
Intervention description: After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). 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 8.0 mg/kg) 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 the trial was to establish the dose-response relation of sugammadex (Org
      25969) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane
      anesthesia for Japanese participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants of American Society of Anesthesiologists (ASA) class 1 - 3;

          -  Participants at least 20 years but under 65 years of age;

          -  Japanese participants;

          -  Participants scheduled for elective surgery in supine position and under sevoflurane
             anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with
             an anticipated duration of about 1.5-3 hours;

          -  Participants who had given written informed consent. This was obtained before the
             investigator or the sub-investigator performed any procedures or assessments for the
             screening, and after the participant was informed about the nature and purpose of the
             study, the study procedures, and the risks and restrictions of the study.

        Exclusion Criteria:

          -  Participants in whom a difficult intubation because of anatomical malformations was
             expected;

          -  Participants known or suspected to have neuromuscular disorders impairing
             neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a
             creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.

          -  Participants known or suspected to have a (family) history of malignant hyperthermia;

          -  Participants known or suspected to have an allergy to narcotics, muscle relaxants or
             other medication used during general anesthesia;

          -  Participants receiving medication expected to interfere with the rocuronium or
             vecuronium given in this trial, based on the dose and time of administration;

          -  Female participants who were pregnant;

          -  Female participants of childbearing potential not using birth control or using only
             oral contraception as birth control;

          -  Participants who were breast-feeding;

          -  Participants who had already participated in study CT 19.4.209A, or in another trial
             with sugammadex;

          -  Participants who had participated in another clinical trial within 6 months of
             entering into study CT 19.4.209A.