Spine SurgeryPhase 4NCT05887375
Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
A Phase 4 study testing Sugammadex, Neostigmine and Glycopyrrolate in people with Spine Surgery and Reversal of Neuromuscular Blockade, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery, Reversal of Neuromuscular Blockade, Urinary Retention Postoperative
- What is being tested?
- Sugammadex, Neostigmine and Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2023to 15 Jan 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- ASA Physical Status I-III
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Subjects requiring elective ambulatory posterior lumbar laminectomy, will receive either an intravenous infusion bolus of Sugammadex (2 mg/kg dosed by actual body weight) or intravenous infusion bolus of Neostigmine (50 μg/kg, up to 5 mg maximum dose) plus Glycopyrrolate (10 μg/kg, up to 1 mg maximum dose). Additionally, all subjects will receive hospital standard of care therapy for their surgery and hospital stay.
- Being tested
- Sugammadex, Neostigmine, Glycopyrrolate, Rocuronium
- Keywords
- Urinary retention, Spine surgery, Sugammadex, Neostigmine, Neuromuscular blockade, Neuromuscular blockade reversal, Cholinesterase Inhibitors, Cholinergic Agents, Physiological Effects of Drugs, Parasympathomimetic, Autonomic Agents
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion, MK-8616
Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.
NeostigmineDrug
Also called Bloxiverz
Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.
GlycopyrrolateDrug
Also called Glycopyrrolate injection, USP
Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight.
RocuroniumDrug
Also called Rocuronium Bromide
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.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex 2 mg/kg | Experimental | Sugammadex 2 mg/kg administered as a single intravenous (IV) dose. Receives: Drug: Sugammadex; Drug: Rocuronium |
| Neostigmine + Glycopyrrolate | Active comparator | 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. Receives: Drug: Neostigmine; Drug: Glycopyrrolate; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Urinary Retention
The difference between sugammadex and neostigmine/glycopyrrolate on the incidence of urinary retention defined as no void more than 6 hours after posterior lumbar spine surgery in ambulatory/short stay patients.
Measured: Up to 6 hours after administration of study intervention
Secondary outcomes (5)
Time to First Micturition
Between patients who received sugammadex and neostigmine/glycopyrrolate - comparison of actual time in minutes to first micturition after surgery.
Measured: Up to 1 day after administration of study intervention
Bladder Scans Required
Between patients who received sugammadex and neostigmine/glycopyrrolate. Number and percentage of patients who required a bladder scan 6 hours after surgery.
Measured: 6 hours after surgery if patient did not void
Urinary Retention Symptoms
Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare urinary retention symptoms, we will administer a questionnaire at 6 hours postoperatively and 24 hours after surgery.
Measured: 24 hours after surgery
Number of Participants Who Received Bladder Catheterization
Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare need for bladder catheterization (straight or Foley).
Measured: 24 hours after surgery
Length of Hospital Stay
Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare length of hospital stay.
Measured: Up to 7 Days after administration of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start3 Aug 2023
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Julie Marshall, University of Missouri-Columbia
- Investigators
- Boris Mraovic, MD, FASA, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887375
- Sponsor's protocol ID
- 2096001
- Other IDs
- MISP Database number 101357
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2023
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea.
PubMed 19352147McLain RF, Kalfas I, Bell GR, Tetzlaff JE, Yoon HJ, Rana M. Comparison of spinal and general anesthesia in lumbar laminectomy surgery: a case-controlled analysis of 400 patients. J Neurosurg Spine. 2005 Jan;2(1):17-22. doi: 10.3171/spi.2005.2.1.0017.
PubMed 15658121Chang Y, Chi KY, Tai TW, Cheng YS, Lee PH, Huang CC, Lee JS. Risk factors for postoperative urinary retention following elective spine surgery: a meta-analysis. Spine J. 2021 Nov;21(11):1802-1811. doi: 10.1016/j.spinee.2021.05.009. Epub 2021 May 18.
PubMed 34015508Cremins M, Vellanky S, McCann G, Mancini M, Sanzari L, Yannopoulos A. Considering healthcare value and associated risk factors with postoperative urinary retention after elective laminectomy. Spine J. 2020 May;20(5):701-707. doi: 10.1016/j.spinee.2020.01.012. Epub 2020 Jan 29.
PubMed 32006710Cha JE, Park SW, Choi YI, et al. Sugammadex use can decrease the incidence of post-operative urinary retention by avoiding anticholinergics: a retrospective study. Anesthesia and Pain Medicine. 2018;13(1):40-46.
Zakaria HM, Lipphardt M, Bazydlo M, Xiao S, Schultz L, Chedid M, Abdulhak M, Schwalb JM, Nerenz D, Easton R, Chang V; MSSIC Investigators. The Preoperative Risks and Two-Year Sequelae of Postoperative Urinary Retention: Analysis of the Michigan Spine Surgery Improvement Collaborative (MSSIC). World Neurosurg. 2020 Jan;133:e619-e626. doi: 10.1016/j.wneu.2019.09.107. Epub 2019 Sep 27.
PubMed 31568914