Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)
Condition: Anesthesia, General
Intervention: Sugammadex; Placebo; Esmeron®
Intervention description: Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.; 0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,; Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Intervention MeSH terms: Bromides; Rocuronium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial was to explore the dose-response relation of sugammadex (Org
      25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15
      minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in
      participants receiving surgery, classified as American Society of Anesthesiologists (ASA)
      class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic
      disease), or class 3 (participant with a severe systemic disease that limits activity, but is
      not incapacitating).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants of ASA class 1 - 3, above or equal to the age of 18 years;

          -  Participants scheduled for surgical procedures with an anticipated duration of
             anesthesia of at least 120 minutes, without further need for muscle relaxation other
             than for intubation;

          -  Participants scheduled for surgical procedures in supine position;

          -  Participants who had given written informed consent.

        Exclusion Criteria:

          -  Participants in whom a difficult intubation because of anatomical malformations was
             expected;

          -  Participants known or suspected to have neuromuscular disorders impairing
             neuromuscular blocking and/or significant renal 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 known to interfere with neuromuscular blocking
             agents, such as anticonvulsants and Mg^2+;

          -  Participants who had already participated in this trial;

          -  Participants who had participated in another clinical trial, not pre-approved by the
             Sponsor, within 30 days of entering into this trial;

          -  Female participants who were pregnant: in females, pregnancy was to be excluded both
             from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours
             before surgery except in females who were not of childbearing potential, i.e. at least
             2 years menopausal or who had undergone tubal ligation or an hysterectomy;

          -  Female participants of childbearing potential not using any of the following methods
             of birth control (for one month): condom or diaphragm with spermicide, vasectomized
             partner (>6 months), intrauterine device (IUD), abstinence;

          -  Female participants who were breast-feeding.