Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

Spine Surgery Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05887375
• Other study ID #: 2096001
• Secondary ID: MISP Database nu
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: August 3, 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 118
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Reversal of Neuromuscular Blockade
• Spine Surgery
• Urinary Retention
• Urinary Retention Postoperative

Intervention

Drug:
• Sugammadex
Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.
• Neostigmine
Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.
• Glycopyrrolate
Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight.
• Rocuronium
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.

Locations

Country	Name	City	State
United States	University Hospital	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & 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. — View 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.

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Bladder urine volume	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
Secondary	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
Secondary	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
Secondary	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