Sugammadex vs Neostigmine/Glycopyrrolate for Urinary Retention After Spinal Surgery

Recruiting in Palo Alto (17 mi)

Overseen byBoris Mraovic, MD, FASA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Missouri-Columbia

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults aged 18 or older, with a physical status classified as ASA I-III, who are undergoing elective ambulatory spine surgery can join. Excluded are those with allergies to study drugs, neuromuscular disorders, severe kidney/liver disease, recent genitourinary procedures or cancer treatments, BPH symptoms, urinary issues or on related meds.

Inclusion Criteria

I am 18 years old or older.

My health is good to moderately impaired.

Exclusion Criteria

I am currently taking medication for bladder problems or water pills.

I have had surgery or treatment for urinary or genital issues, including cancer, in the past year.

I have a diagnosed or suspected muscle or nerve disorder.

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Treatment Details

Interventions

Neostigmine/Glycopyrrolate (Procedure)
Sugammadex (Procedure)

Trial OverviewThe trial is testing if Sugammadex is better than Neostigmine/Glycopyrrolate at preventing urinary retention after spine surgery when reversing the effects of Rocuronium—anesthesia-related muscle relaxation.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Sugammadex 2 mg/kgExperimental Treatment2 Interventions

Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.

Group II: Neostigmine + GlycopyrrolateActive Control3 Interventions

Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose.