Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Bromides; Glycopyrrolate; Neostigmine; Rocuronium

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)