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| ID | Type | Description | Link |
|---|---|---|---|
| MISP Database number 101357 | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex 2 mg/kg | Experimental | Sugammadex 2 mg/kg administered as a single intravenous (IV) dose. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Micturition | Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare actual times of micturition we will analyze the proportion of patients (percentages) voided at 6, 9, 12 and 24 hours. | Up to 1 day after administration of study intervention |
| Bladder urine volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Mraovic, MD, FASA | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19352147 | Background | 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. | |
| 15658121 | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| Neostigmine | Drug | Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight. |
|
|
| Glycopyrrolate | Drug | Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight. |
|
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| 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. |
|
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Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare bladder urine volumes in milliliters (mL) we will perform bladder ultrasound scan at 6 hours postoperatively if patients did not void. |
| Up to 6 hours after administration of study intervention |
| 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 on postoperative day 1. | Up to 1 day after administration of study intervention |
| Bladder catheterization | Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare need for bladder catheterization (straight or Foley). | Up to 1 Day after administration of study intervention |
| Length of hospital stay | Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare length of hospital stay. | Up to 7 Days after administration of study intervention |
| 34015508 | 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. |
| 32006710 | 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. |
| 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. |
| 31568914 | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |