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ENROLLING BY INVITATION
NCT05887375
PHASE4

Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

Sponsor: University of Missouri-Columbia

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2023-08-03

Completion Date

2026-06

Last Updated

2025-09-02

Healthy Volunteers

No

Interventions

DRUG

Sugammadex

Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.

DRUG

Neostigmine

Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.

DRUG

Glycopyrrolate

Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight.

DRUG

Rocuronium

To achieve NMB, participants will receive the steroidal neuromuscular blocking agent Rocuronium Bromide administered via IV infusion and dosed according to participant actual body weight. It will be used per label to maintain muscle relaxation as an adjunct to general anesthesia.

Locations (1)

University Hospital

Columbia, Missouri, United States