Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4.334) (P05774)
Condition: Anesthesia
Intervention: Sugammadex; Neostigmine; Rocuronium
Intervention description: Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide.; Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care.; Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide.
Intervention MeSH terms: Bromides; Rocuronium; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to compare the incidence of

      residual neuromuscular blockade at the time of tracheal extubation after reversal of
      rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg
      neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch
      (T4/T1) ratio of

      < 0.90.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or females who are >= 18 and <= 65 years of age

          -  classified by the American Society of Anesthesiologists (ASA) as Class 1 or 2 or 3;

          -  Body Mass Index (BMI) of <35 kg/m^2;

          -  is scheduled to undergo an elective open abdominal surgical procedure under general
             anesthesia requiring neuromuscular relaxation using rocuronium bromide (maintenance of
             neuromuscular blockade if required) for endotracheal intubation and requiring
             neuromuscular blockade reversal;

          -  is scheduled to undergo a surgical procedure in a position that does not interfere
             with the use of TOF-Watch® SX;

          -  is scheduled to undergo an elective open abdominal procedure expected to last <=4
             hours (from start of skin incision to end of last stitch of the skin);

          -  have given written informed consent.

        Exclusion Criteria:

          -  participants for whom a difficult intubation is expected because of anatomical
             malformations;

          -  is known or suspected to have neuromuscular disorders that may impair neuromuscular
             blockade;

          -  is known or suspected to have significant renal dysfunction (e.g., creatinine
             clearance < 30 mL/min) ;

          -  is known or suspected to have significant hepatic dysfunction;

          -  is known or suspected to have a (family) history of malignant hyperthermia;

          -  is known or suspected to have an allergy to opioids, muscle relaxants or other
             medications used during general anesthesia;

          -  participants for whom the use of neostigmine and/or glycopyrrolate may be
             contraindicated;

          -  participants for whom a pre-established need for postoperative intensive care
             admission is expected;

          -  pregnant or breast-feeding females;

          -  have participated in a previous sugammadex clinical trial;