Back to resultsSugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
Primary Purpose
Spine Surgery, Reversal of Neuromuscular Blockade, Urinary Retention Postoperative
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Glycopyrrolate
Rocuronium
Sponsored by
About this trial
This is an interventional treatment trial for Spine Surgery focused on measuring Urinary retention, Spine surgery, Sugammadex, Neostigmine, Neuromuscular blockade, Neuromuscular blockade reversal, Cholinesterase Inhibitors, Cholinergic Agents, Physiological Effects of Drugs, Parasympathomimetic, Autonomic Agents
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)
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sugammadex 2 mg/kg
Neostigmine + Glycopyrrolate
Arm Description
Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Bladder catheterization
Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare need for bladder catheterization (straight or Foley).
Length of hospital stay
Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare length of hospital stay.
Full Information
NCT ID
NCT05887375
First Posted
April 25, 2023
Last Updated
September 28, 2023
Sponsor
University of Missouri-Columbia
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05887375
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex 2 mg/kg
Arm Type
Experimental
Arm Description
Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.
Arm Title
Neostigmine + Glycopyrrolate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion, MK-8616
Intervention Description
Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Other Intervention Name(s)
Bloxiverz
Intervention Description
Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Other Intervention Name(s)
Glycopyrrolate injection, USP
Intervention Description
Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Rocuronium Bromide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of urinary retention
Description
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.
Time Frame
Up to 6 hours after administration of study intervention
Secondary Outcome Measure Information:
Title
Micturition
Description
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.
Time Frame
Up to 1 day after administration of study intervention
Title
Bladder urine volume
Description
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.
Time Frame
Up to 6 hours after administration of study intervention
Title
Urinary retention symptoms
Description
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.
Time Frame
Up to 1 day after administration of study intervention
Title
Bladder catheterization
Description
Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare need for bladder catheterization (straight or Foley).
Time Frame
Up to 1 Day after administration of study intervention
Title
Length of hospital stay
Description
Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare length of hospital stay.
Time Frame
Up to 7 Days after administration of study intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Mraovic, MD, FASA
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19352147
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.
Results Reference
background
PubMed Identifier
15658121
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.
Results Reference
background
PubMed Identifier
34015508
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.
Results Reference
background
PubMed Identifier
32006710
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
31568914
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.
Results Reference
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Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
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