Investigation of Sugammadex in Outpatient Urological Procedures
Malignant Neoplasms of Urinary Tract, Bladder Cancer
About this trial
This is an interventional supportive care trial for Malignant Neoplasms of Urinary Tract focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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)
- Male or Females who are >= 18 years of age
- Classified by the American Society of Anesthesiologists (ASA) as Class I - IV
- Candidate for use of laryngeal mask airway (LMA)
- Able to give consent
Exclusion Criteria:
- Severe renal impairment as measured eGFR less than 30 per institutional laboratory.
- Females who are pregnant or might be pregnant or are breast-feeding.
- Females who have been diagnosed with breast cancer and currently taking Toremifene
- Is known or suspected to have significant hepatic dysfunction, with AST & ALT 3 times above UNL per institutional laboratory.
- Is known or suspected to have a (family) history of malignant hyperthermia
- Is known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia
- Is known or suspected to have neuromuscular disorders (ex: myasthenia gravis)
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sugammadex
Standard of Care - Neostigmine/Glycopyrrolate
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.
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. Neostigmine/Glycopyrrolate administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70 mcg/kg of Neostigmine with 14 mcg/kg Glycopyrrolate administered simultaneously over a period of one minute up to 5 mg.