Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)
Condition: Anesthesia, General
Intervention: Rocuronium; Sugammadex; Neostigmine; Atropine
Intervention description: Participants will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After this dose, maintenance doses of 0.1-0.2 mg.kg-1 rocuronium may be given.; After the last dose of rocuronium has been administered, participants will receive, according to the randomization, a single bolus dose of 4.0 mg.kg-1 sugammadex at 1-2 PTC.; After the last dose of rocuronium has been administered, participants will receive, according to the randomization, 50 μg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.; After the last dose of rocuronium has been administered, participants will receive, according to randomization, 10 μg.kg-1 atropine (with neostigmine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.
Intervention MeSH terms: Atropine; Bromides; Rocuronium; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current trial was designed to demonstrate faster recovery from a neuromuscular blockade
      (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1
      sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in
      participants undergoing laparoscopic cholecystectomy or appendectomy under propofol
      anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit
      (PACU) length of stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants of American Society of Anesthesiologists class 1-3

          -  Participants of age above or equal to the age of 18 years

          -  Participants who are scheduled to undergo a laparoscopic cholecystectomy or
             appendectomy under general anesthesia requiring neuromuscular relaxation with
             rocuronium, and if applicable, maintenance of neuromuscular blockade

          -  Participants who have given written informed consent

        Exclusion Criteria:

          -  Participants in whom a difficult intubation because of anatomical malformations is
             expected

          -  Participants known or suspected to have neuromuscular disorders affecting NMB

          -  Participants known or suspected to have a significant renal dysfunction

          -  Participants known or suspected to have a severe hepatic dysfunction

          -  Participants known or suspected to have (family) history of malignant hyperthermia

          -  Participants known or suspected to have an allergy to opioids, muscle relaxants or
             other medication used during general anesthesia

          -  Participants in whom the use of neostigmine and/or atropine is contraindicated

          -  Female participants who are pregnant (pregnancy will be excluded for women both from
             medical history and by a human chorionic gonadotropin (hCG) test within 24h before
             surgery, except for women who are not of childbearing potential, i.e. at least 2 years
             menopausal or have undergone tubal ligation or a hysterectomy)

          -  Female participants who are breast-feeding

          -  Participants who participated in another clinical trial not pre-approved by the
             sponsor, within 30 days of entering into trial 19.4.318 (P05699)

          -  Participants who have already participated in a sugammadex trial