Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)
Condition: Neuromuscular Blockade
Intervention: rocuronium; sugammadex; succinylcholine
Intervention description: A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block.; At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 Post-Tetanic Count (PTC), 4.0 mg/kg of sugammadex will be administered.; A single bolus intubation dose of 1.0 mg/kg succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade.
Intervention MeSH terms: Bromides; Rocuronium; Succinylcholine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A multi-center, randomized, parallel group, comparative, active controlled, safety assessor
      blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine
      alone in subjects undergoing short surgical procedures in out-patient surgicenters. The
      primary objective was to evaluate changes in plasma potassium levels after treatment with
      rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical
      procedures in out-patient surgicenters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects >=18 years of age;

          -  ASA Class 1-3;

          -  Subjects with a Body Mass Index (BMI) of < 35 kg/m^2 ;

          -  Subjects scheduled to undergo an elective short procedure with general anesthesia
             requiring neuromuscular relaxation and endotracheal intubation in outpatient
             surgicenters;

          -  Subjects scheduled to undergo an elective surgical procedure expected to last 1.5
             hours or less (from end of intubation to end of suturing/stapling of skin);

          -  Subjects who are scheduled to undergo an elective surgical procedures that allows
             access to the arm for TOF-Watch® SX monitoring;

          -  Subjects who have given written informed consent.

        Exclusion Criteria:

          -  Subjects known to have ischemic heart disease or a history of myocardial infarction;

          -  Subjects in whom a difficult intubation is expected because of anatomical
             malformations;

          -  Subjects with medical conditions and/or undergoing surgical procedures that are not
             compatible with the use of the TOF-Watch SX (e.g., injuries to the thumbs/distal
             forearms, bilateral ulnar nerve damage or subjects with cardiac pacemakers);

          -  Subjects known or suspected to have neuromuscular disorders impairing neuromuscular
             blockade (e.g., subjects with myasthenia gravis);

          -  Subjects who would require the use of pneumatic tourniquet during the surgical
             procedure;

          -  Subjects known or suspected to have significant renal dysfunction (e.g., creatinine
             clearance < 30 mL per min);

          -  Subjects known or suspected to have significant hepatic dysfunction;

          -  Subjects known or suspected to have a (family) history of malignant hyperthermia;

          -  Subjects known or suspected to be hypersensitive to sugammadex or other cyclodextrins
             or rocuronium or any of its excipients;

          -  Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants,
             or other medications used during general anesthesia;

          -  Subjects for whom a pre-established need for post operative intensive care admission
             and/or hospital admission is expected;

          -  Subjects for whom an intra operative IV administration of fluids that contain
             potassium is expected;

          -  Female subjects who are pregnant;

          -  Female subjects who are breast-feeding;

          -  Subjects who have participated in a previous sugammadex trial;

          -  Subjects who have participated in another investigational drug trial within 30 days
             before entering into clinical trial (CT) 19.4.319 (P05700) unless pre-approved by the
             sponsor.