Skip to main content
OpenTrials
Completed

NCT Number: NCT05887375

Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sugammadex

Drug

Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.

Other names: Bridion, MK-8616

Neostigmine

Drug

Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.

Other names: Bloxiverz

Glycopyrrolate

Drug

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

Rocuronium

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.