Sugammadex Vs Neostigmine/glycopyrrolate on Urinary Retention After Spine Surgery

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · May 24, 2023

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ClinConnect Summary

This study is comparing two drugs used to reverse muscle relaxation after spine surgery to see which one leads to fewer problems with urinating. People will receive either sugammadex (2 mg/kg) or the standard combo neostigmine plus glycopyrrolate after rocuronium anesthesia. The trial is designed so that neither the patient nor the care team knows which drug was given (double- and quadruple-masked), and it will look at whether sugammadex affects the chance of urinary retention within the first 6 hours after drug administration, as well as other urinary outcomes and hospital stay.

If you’re considering participation, you’d need to be 18 or older and generally healthy enough for ambulatory posterior lumbar laminectomy (spine surgery). Key inclusion criteria include adult age and a body health status from I to III. Exclusions include allergy to study drugs, any known neuromuscular or significant kidney or liver disease, recent urinary problems or surgery, current urinary medications, and other factors that could affect urination. Participants get a single IV dose of the assigned reversal drug after surgery and then are followed with tests and questionnaires about urination up to 24 hours and up to a week in the hospital. The study is currently enrolling about 118 people, and results are not yet available.

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Eligibility criteria

• 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)