Investigation of Sugammadex in Outpatient Urological Procedures
Condition: Malignant Neoplasms of Urinary Tract; Bladder Cancer
MeSH terms: Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms
Intervention: Rocuronium; Sugammadex; Neostigmine; Glycopyrrolate
Intervention description: Experimental: Sugammadex Participants to have cystoscopy with bladder tumor resection. Rocuronium used to induce the neuromuscular blockade and given in a rapid sequence for endotracheal intubation at a dose of 0.45 mg/kg of Ideal Body Weight. If maintenance is needed for continued relaxation then a dose of 0.15 mg/kg of Ideal Body Weight repeated as necessary.; Sugammadex administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.; 70 mcg/kg by vein to reverse the muscle relaxation.; 14 mcg/kg by vein to reverse the muscle relaxation.
Intervention MeSH terms: Glycopyrrolate; Bromides; Rocuronium; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Malignant neoplasms of urinary tract; Bladder cancer; Outpatient bladder procedures; Outpatient cystoscopy procedure; Transurethral resection of the bladder; TURB; Rocuronium; Rocuronium Bromide; Zemuron; Sugammadex; Neostigmine; Glycopyrrolate

Summary:

      The goal of this clinical research study is to determine whether using sugammadex, given with
      a standard muscle relaxation drug during bladder surgeries, improves anesthesia conditions
      and recovery time.

      During some bladder operations, your muscles must be completely relaxed. Muscle relaxation
      drugs cause the muscles to relax, including the respiratory muscles, and as a result
      artificial ventilation is needed to help you breathe. Sugammadex and other standard drugs
      reverse the effect of the muscle relaxation drugs, allowing you to breathe on your own after
      the operation.

      Study Groups:

      If you agree to take part in this study, you will be randomly assigned (as in the flip of a
      coin) to 1 of 2 study groups. This is done because no one knows if one study group is better,
      the same, or worse than the other group:

        -  If you are in Group 1, you will receive sugammadex to reverse the muscle relaxation.

        -  If you are in Group 2, you will receive the standard of care
           (neostigmine/glycopyrrolate) to reverse the muscle relaxation.

      You and the surgeon will not know which group you have been assigned to. However, the
      anesthesiologist and study staff will know.

      Length of Study:

      You will be on study for up to 1 week after the cystoscopy. If you are unable to have the
      procedure performed, you may be taken off study early.

      This is an investigational study. Sugammadex and neostigmine/glycopyrrolate are all FDA
      approved and commercially available to reverse muscle relaxation. The comparison of these
      drugs is investigational.

      Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is scheduled to undergo cystoscopy with bladder resection procedure under general
             anesthesia requiring neuromuscular relaxation using rocuronium bromide to secure
             airway and requiring neuromuscular reversal at The University of Texas MD Anderson
             Cancer Center - Mays Clinic (ACB-outpatient)

          2. Male or Females who are >= 18 years of age

          3. Classified by the American Society of Anesthesiologists (ASA) as Class I - IV

          4. Candidate for use of laryngeal mask airway (LMA)

          5. Able to give consent

        Exclusion Criteria:

          1. Severe renal impairment as measured eGFR less than 30 per institutional laboratory.

          2. Females who are pregnant or might be pregnant or are breast-feeding.

          3. Females who have been diagnosed with breast cancer and currently taking Toremifene

          4. Is known or suspected to have significant hepatic dysfunction, with AST & ALT 3 times
             above UNL per institutional laboratory.

          5. Is known or suspected to have a (family) history of malignant hyperthermia

          6. Is known or suspected to have an allergy to opioids, muscle relaxants or other
             medications used during general anesthesia

          7. Is known or suspected to have neuromuscular disorders (ex: myasthenia gravis)