Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients
Condition: Neuromuscular Blockade
Intervention: Sugammadex; Neostigmine w/ Glycopyrrolate
Intervention description: Sugammadex 2 mg/kg; Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This prospective, randomized, double blinded study is intended to enroll a total of 92
      patients undergoing thoracic surgery with general endotracheal anesthesia at Parkland
      Hospital. Patients will be randomized to receive either neostigmine or sugammadex for
      reversal of neuromuscular blockade. Merck, Inc. will supply the sugammadex through an
      agreement with Parkland Investigational Drug Services. Neostigmine is readily available for
      anesthesiologists to use and is the current standard of care for reversal of neuromuscular
      blockade. A standardized anesthetic protocol that is usual and customary for the type of
      operation the patient is having will be provided to the anesthesia teams of enrolled
      subjects. The remainder of the anesthetic care of the subject will not deviate from the
      standard of care. The surgeon, anesthesia team, postoperative recovery nurse, and research
      assistant will be blinded as to which reversal drug the patient receives. The only individual
      that will know to which drug the patient has been randomized will be the pharmacist who draws
      up the medication(s). A blinded research assistant will record postoperative outcomes and the
      patient will be followed 90 minutes postoperatively for any adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-80 years old

          -  Undergoing non-emergent thoracic surgery

          -  ASA physical status classification 2 to 4

          -  Willing and able to consent in English or Spanish

          -  No personal history of neuromuscular disease

        Exclusion Criteria:

          -  Age less than 18 or older than 80

          -  Patient does not speak English or Spanish

          -  Planned postoperative intubation or ICU admission

          -  Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium

          -  Family or personal history of malignant hyperthermia

          -  Patient refusal

          -  Monitored anesthesia care (MAC) or regional anesthesia planned

          -  Pregnant or nursing women

          -  "Stat" (emergent) cases

          -  Estimated creatinine clearance <30 mL/min

          -  Pre-existing muscle weakness of any etiology

          -  Patients on toremifene (a selective estrogen receptor modulator)

          -  Women on oral contraceptives who do not wish to use a non-hormonal method of
             contraception for 7 days following surgery