Recovery of Diaphragmatic Function After Neuromuscular Blockade and Sugammadex
Condition: Diaphragmatic Dysfunction; Muscle Weakness; Muscle Fatigue
MeSH terms: Muscle Weakness
Intervention: sugammadex 2mg/kg; neostigmine; sugammadex 4mg/kg; placebo; Single rocuronium dose; Repeated rocuronium dose; Continuous rocuronium infusion
Intervention MeSH terms: Rocuronium; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle
      activity is well known. However, since the availability of sugammadex, to our knowledge, no
      study has been conducted to evaluate the effect of this novel product on these muscles.

      Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking
      agents and their reversal agents we might see a different activity of the respiratory
      muscles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Each participant must have the mental capacity to decide whether he/she takes part in
             the trial or not. Each participant must voluntarily give his/her written informed
             consent. In case a participant is physically unable to give a written informed
             consent, a legal representative is to perform this.

          -  Each participant must be at least eighteen years of age. Participants can be of either
             sex and of any ethnical background.

          -  Each participant must meet the American Society of Anesthesiologists class II, II or
             III criteria.

          -  Each participant must be scheduled for intracranial surgery. During general anesthesia
             rocuronium must be used as a neuromuscular blocking agent.

          -  Each participant must be a suitable candidate for the rapid reversal of the
             neuromuscular blockade.

          -  Each female participant of sexually active age and of childbearing potential must
             agree to the use of a medically accepted method of contraception through seven days
             after the day of surgery. Postmenopausal (defined as at least twelve consecutive
             months without spontaneous menstrual period) women are not obliged to use
             contraceptives.

        Exclusion Criteria:

          -  The participant is known or suspected to have a neuromuscular disorder.

          -  The participant is known or suspected to have an allergic reaction to sugammadex,
             rocuronium, anesthetic or narcotic medications, or any drugs used during general
             anesthesia.

          -  The participant is known or suspected to have an anatomical malformation impeding a
             proper intubation.

          -  The participant is known or suspected to have a history of malignant hyperthermia.

          -  The participant is pregnant (or intends to become pregnant within the presurgical
             period) or lactating.

          -  The participant is known to have a renal insufficiency (defined as a serum creatinine
             concentration of two times the upper limit, or a glomerular filtration rate of less
             than 60 ml/min).

          -  The participant is known or suspected to have a chronic obstructive pulmonary disease
             GOLD classification 2 or higher or has any respiratory disease that impairs his
             respiratory function to a NYHA III level or worse.

          -  The participant is known to have an infection of the upper or lower airways, as
             diagnosed by clinical or laboratory findings.

          -  The participant is known or suspected to have congestive heart failure.

          -  The participant is obese, as defined by a body mass index of 30 kg/m2 or more.

          -  The participant is known or suspected to have a major hepatic dysfunction.

          -  The participant has received or is scheduled to receive toremifene and/or an
             intravenous administration of fusidic acid within a time span of twenty-four hours
             before and twenty-four hours after the surgery.

          -  The participant is known or suspected to have any condition contraindicating the
             administration of sugammadex, neostigmine, glycopyrrolate or placebo.

          -  The participant is known or suspected to be directly involved in this study and/or is
             employed by or is a family member of any person employed by the investigator, at the
             investigational site, or by the sponsor.