Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
NCT05887375 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2026-05-05
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.
Conditions
- Spine Surgery
- Reversal of Neuromuscular Blockade
- Urinary Retention Postoperative
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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Missouri-Columbia
lead OTHER
Principal Investigators
-
Boris Mraovic, MD, FASA · University of Missouri-Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-03
- Primary Completion
- 2026-01-15
- Completion
- 2026-01-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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