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Sugammadex vs Neostigmine/Glycopyrrolate for Urinary Retention After Spinal Surgery

Phase 4

Waitlist Available

Led By Boris Mraovic, MD, FASA

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

ASA Physical Status I-III

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 hours after administration of study intervention

Awards & highlights

Study Summary

This trial compares drugs used to reverse muscle relaxants after spine surgery to see which one reduces the risk of having trouble peeing after surgery.

Who is the study for?

Adults aged 18 or older, with a physical status classified as ASA I-III, who are undergoing elective ambulatory spine surgery can join. Excluded are those with allergies to study drugs, neuromuscular disorders, severe kidney/liver disease, recent genitourinary procedures or cancer treatments, BPH symptoms, urinary issues or on related meds.Check my eligibility

What is being tested?

The trial is testing if Sugammadex is better than Neostigmine/Glycopyrrolate at preventing urinary retention after spine surgery when reversing the effects of Rocuronium—anesthesia-related muscle relaxation.See study design

What are the potential side effects?

Possible side effects include allergic reactions and heart rhythm changes for both drug options. Sugammadex may cause bleeding issues and mild gastrointestinal symptoms; Neostigmine/Glycopyrrolate might lead to vision problems, dry mouth and difficulty urinating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My health is good to moderately impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 hours after administration of study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 hours after administration of study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 hours after administration of study intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of urinary retention

Secondary outcome measures

Bladder catheterization

Bladder urine volume

Length of hospital stay

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sugammadex 2 mg/kgExperimental Treatment2 Interventions

Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.

Group II: Neostigmine + GlycopyrrolateActive Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sugammadex

2017

Completed Phase 4

~3410

Rocuronium

2014

Completed Phase 4

~1680

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

361 Previous Clinical Trials

627,876 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,856 Total Patients Enrolled

Boris Mraovic, MD, FASAPrincipal InvestigatorUniversity of Missouri-Columbia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially sanctioned Sugammadex 2 mg/kg as a viable treatment option?

"There is extensive clinical data attesting to Sugammadex 2 mg/kg's safety, so it was allocated a score of 3."

Answered by AI

Are participants being accepted to this research endeavor presently?

"The data available on clinicaltrials.gov reveals that this experiment currently is not recruiting participants, even though it was last edited on September 28th 2023. However, there are 47 other research studies actively seeking patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

Boris Mraovic 2023. "Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05887375.

All > Urinary Retention