Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
Condition: Surgical Procedures, Elective
Intervention: Sugammadex; Neostigmine; Glycopyrrolate
Intervention description: sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery; neostigmine, per usual practice; glycopyrrolate per usual practice
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the incidence of residual neuromuscular blockade in participants who
      undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo
      reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 or 2 or 3

          -  Scheduled to undergo an elective abdominal surgical procedure under general
             anesthesia; and:

               -  expected to undergo neuromuscular relaxation with rocuronium for

        endotracheal intubation; and

          -  expected to require at least one maintenance dose of rocuronium; and

          -  expected to require active reversal of neuromuscular blockade; and

          -  expected to require clinical or subjective neuromuscular monitoring only; and

          -  expected to recover in the PACU

               -  Arm that is accessible for measuring the TOF ratio in the PACU

               -  Sexually active female patient of child-bearing potential must agree to use a

        medically accepted method of contraception through seven days after receiving

        protocol-specified medication.

        Exclusion Criteria:

          -  Anatomical malformations that may lead to difficult intubation

          -  Neuromuscular disorder(s) that may affect neuromuscular blockade and/or trial
             assessments

          -  Dialysis-dependent or has or is suspected of having severe renal insufficiency

          -  Significant hepatic dysfunction

          -  Family history of malignant hyperthermia

          -  Cardiac pacemaker

          -  Allergy to study treatments or its/their excipients, to opioids / opiates, sugammadex,
             muscle relaxants or their excipients, or other medication(s) used during general
             anesthesia

          -  Toremifene before or within 24 hours of study drug administration

          -  Scheduled for an overnight stay (or >12 hours) in PACU

          -  Expected transfer to an Intensive Care Unit after surgery

          -  Pregnant, intention to become pregnant between randomization and the Day 30 pregnancy
             follow-up visit

          -  Breast-feeding.

          -  Investigational drug(s) within 30 days of randomization on this study

          -  Participation in any other clinical trial within 30 days, inclusive, of signing the
             informed consent form of the current trial

          -  Participant or family member is among the personnel of the investigational or Sponsor
             staff directly involved with this trial