drugset / Trial / NCT05887375
Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2023-08-03
- Primary completion
- 2026-01-15
- Completion
- 2026-01-15
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Neostigmine | Other / unclassified | 50 ug/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 2 mg/kg | Intravenous |
| Comparator | Glycopyrrolate | Small molecule | 10 ug/kg | Intravenous |
| Background | Rocuronium | Other / unclassified | — | Intravenous |