Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

NCT05887375 | Completed Phase 4 FDA Drug

• 2 other identifiers: 2096001MISP Database number 101357
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Urinary retention; Spine surgery; Sugammadex; Neostigmine; Neuromuscular blockade; Neuromuscular blockade reversal; Cholinesterase Inhibitors; Cholinergic Agents; Physiological Effects of Drugs; Parasympathomimetic; Autonomic Agents

Outcome Measures

Primary Outcomes (1)

• Incidence of 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.

  Up to 6 hours after administration of study intervention

Secondary Outcomes (5)

• Micturition

  Up to 1 day after administration of study intervention

• Bladder urine volume

  Up to 6 hours after administration of study intervention

• Urinary retention symptoms

  Up to 1 day after administration of study intervention

• Bladder catheterization

  Up to 1 Day after administration of study intervention

• Length of hospital stay

  Up to 7 Days after administration of study intervention

Study Arms (2)

Sugammadex 2 mg/kg

EXPERIMENTAL

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

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.

Drug: Neostigmine; Drug: Glycopyrrolate; Drug: Rocuronium

Interventions

Sugammadex DRUG

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

Also known as: Bridion, MK-8616

Sugammadex 2 mg/kg

Neostigmine DRUG

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

Also known as: Bloxiverz

Neostigmine + Glycopyrrolate

Glycopyrrolate DRUG

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

Also known as: Glycopyrrolate injection, USP

Neostigmine + Glycopyrrolate

Rocuronium DRUG

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.

Also known as: Rocuronium Bromide

Neostigmine + Glycopyrrolate; Sugammadex 2 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• ASA Physical Status I-III

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

Related Publications (6)

• 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.

  PMID: 19352147 BACKGROUND

• McLain 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.

  PMID: 15658121 BACKGROUND

• Chang 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.

  PMID: 34015508 BACKGROUND

• Cremins 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.

  PMID: 32006710 BACKGROUND

• Cha 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.

  BACKGROUND

• 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.

  PMID: 31568914 BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Interventions

Sugammadex; Neostigmine; Glycopyrrolate; Rocuronium

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds

Study Officials

• Boris Mraovic, MD, FASA

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: June 2, 2023
• Study Start: August 3, 2023
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)