Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

April 28, 2026 updated by: Julie Marshall, University of Missouri-Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sugammadex 2 mg/kg
Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.
Drug: Sugammadex
Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.
Other Names:
  • Bridion
  • MK-8616
Drug: 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.
Other Names:
  • Rocuronium Bromide
Active Comparator: Neostigmine + Glycopyrrolate
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.
Drug: 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.
Other Names:
  • Rocuronium Bromide
Drug: Neostigmine
Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.
Other Names:
  • Bloxiverz
Drug: Glycopyrrolate
Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight.
Other Names:
  • Glycopyrrolate injection, USP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of urinary retention
Time Frame: Up to 6 hours after administration of study intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Micturition
Time Frame: Up to 1 day after administration of study intervention
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
Time Frame: Up to 6 hours after administration of study intervention
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
Time Frame: Up to 1 day after administration of study intervention
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
Time Frame: Up to 1 Day after administration of study intervention
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
Time Frame: Up to 7 Days after administration of study intervention
Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare length of hospital stay.
Up to 7 Days after administration of study intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Boris Mraovic, MD, FASA, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2023

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2096001
  • MISP Database number 101357 (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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