Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)
Condition: Anesthesia, General
Intervention: Sugammadex; Rocuronium; Sevoflurane; Propofol
Intervention description: Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium; Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium; Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.; Propofol IV administered for induction and maintenance of anesthesia, based on randomization.
Intervention MeSH terms: Bromides; Propofol; Sevoflurane; Rocuronium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of the trial was to show equivalence in recovery from neuromuscular block after
      a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after
      continuous infusion of rocuronium, between participants receiving maintenance anesthesia
      using propofol and participants receiving sevoflurane, to investigate the safety and to
      compare the plasma levels of rocuronium in participants after continuous infusion of
      rocuronium and before the administration of sugammadex, under either propofol or sevoflurane
      anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants at least 20 years but under 65 years of age;

          -  Participants of American Society of Anesthesiologists (ASA) class 1-3;

          -  Participants scheduled for a surgical procedure under general anesthesia requiring
             neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an
             anticipated duration of surgery between 2 and 5 hours;

          -  Participants scheduled for a surgical procedure in supine position;

          -  Participants who had given written informed consent.

        Exclusion Criteria:

          -  Participants in whom difficult intubation was expected because of anatomical
             malformations;

          -  Participants known or suspected to have neuromuscular disorders affecting NMB and/or
             significant renal dysfunction. In Germany, this also included serum creatinine and
             blood urea nitrogen outside local reference ranges;

          -  Participants known or suspected to have a (family) history of malignant hyperthermia;

          -  Participants known or suspected to have an allergy to medications used during general
             anesthesia;

          -  Participants receiving medication interfering with NMBAs, such as antibiotics,
             anticonvulsants and Mg^2+; based on the dose and time of administration;

          -  Pregnant or lactating females;

          -  Female participants of childbearing potential not using any birth control or using
             only hormonal contraception as birth control;

          -  Participants who had already participated in trial CT 19.4.312, or in another trial
             with sugammadex;

          -  Participants who had participated in another clinical trial, not pre-approved by
             Organon, within 30 days of entering into CT 19.4.312.