Clinical trial NCT05887375: Sugammadex Vs Neostigmine/glycopyrrolate on Urinary Retention After Spine Surgery
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
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
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-06-02
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Incidence of urinary retention
timeFrame: Up to 6 hours after administration of study intervention
Secondary outcomes:
measure: Micturition
timeFrame: Up to 1 day after administration of study intervention
measure: Bladder urine volume
timeFrame: Up to 6 hours after administration of study intervention
measure: Urinary retention symptoms
timeFrame: Up to 1 day after administration of study intervention
measure: Bladder catheterization
timeFrame: Up to 1 Day after administration of study intervention
measure: Length of hospital stay
timeFrame: Up to 7 Days after administration of study intervention
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Boris Mraovic, MD, FASA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.