Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

A Double-blind, Randomized, Parallel Group Study to Compare Rocuronium Reversal With Sugammadex (Bridion®) Versus Neostigmine/Glycopyrrolate and the Incidence of Urinary Retention After Elective Ambulatory Posterior Lumbar Laminectomy

This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the incidence of urinary retention after subjects undergo elective ambulatory spine surgery.

Subjects requiring elective ambulatory posterior lumbar laminectomy, will receive either an intravenous infusion bolus of Sugammadex (2 mg/kg dosed by actual body weight) or intravenous infusion bolus of Neostigmine (50 μg/kg, up to 5 mg maximum dose) plus Glycopyrrolate (10 μg/kg, up to 1 mg maximum dose). Additionally, all subjects will receive hospital standard of care therapy for their surgery and hospital stay.

Inclusion Criteria:

• Age ≥ 18 years
• ASA Physical Status I-III

Exclusion Criteria:

• Inability to obtain written informed consent
• Allergy to medications used in the protocol
• Known or suspected neuromuscular disorders
• Significant renal disease with a serum creatinine ≥ 2 mg/dL
• Significant liver disease
• A family history of malignant hyperthermia
• History of genitourinary surgery, cancer, or radiation within the last year
• Currently prescribed urological medications or diuretics
• BPH or symptoms of BPH (interrupted or weak urine stream or wake up to urinate more than two times per night)
• History or diagnosis of urinary incontinence or urinary retention
• History of PONV with use of scopolamine
• Use of Foley catheter pre- or intra- operatively
• Perioperative medications that influence micturition (e.g., diuretics or intraoperative anticholinergic medication use other than NMB reversal)