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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
Must not have
Currently prescribed urological medications or diuretics
Known or suspected neuromuscular disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 hours after administration of study intervention
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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.
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.
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 belowSelect...
I am 18 years old or older.
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My health is good to moderately impaired.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for bladder problems or water pills.
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I have a diagnosed or suspected muscle or nerve disorder.
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My kidney function is impaired with high creatinine levels.
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I have a serious liver condition.
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I have used or will use a Foley catheter during surgery.
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My family has a history of malignant hyperthermia.
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I am not on medications that affect urination related to surgery.
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I have BPH or symptoms like weak urine flow or waking up often at night to urinate.
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I have a history of problems controlling my urine or emptying my bladder.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of urinary retention
Secondary study objectives
Bladder catheterization
Bladder urine volume
Length of hospital stay
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
381 Previous Clinical Trials
628,694 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,683 Total Patients Enrolled
Boris Mraovic, MD, FASAPrincipal InvestigatorUniversity of Missouri-Columbia