A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

Study Overview
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Brief Summary
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This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.

Official Title
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Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

Conditions
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Bladder Spasms

Intervention / Treatment
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* Drug: Magnesium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Be undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center. Exclusion Criteria: Are unable to grant informed consent or comply with study procedure. Allergy or known sensitivity to magnesium or Renacidin. Expected or high risk of bladder extravasation. Ongoing atrial fibrillation prior to surgery. Are undergoing emergency surgery. Are pregnant. Known hypermagnesemia. Patients with neuromuscular weakness (e.g., Myasthenia gravis) due to magnesium's muscle weakening effect. Patients with myocardial compromise or cardiac conduction defects because of magnesium's anti-inotropic effects. Patients with renal insufficiency, glomerular filtration rate less than 30, since Magnesium is eliminated by the kidneys resulting in exaggerated rise in serum magnesium. Patients with concomitant use of a calcium channel blocker since magnesium sulfate could act synergistically to suppress muscular contractility.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium Group<br>Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery. | Drug: Magnesium<br>* Intravenous infusion, load 50 mg/Kg with infusion of 15 mg/Kg/hour<br>|
| Placebo Comparator: Placebo Group<br>Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery. | Drug: Placebo<br>* Equivalent volume of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bladder spasm | Number of subjects to experience bladder spasms | Post-operative, approximately 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bladder spasm above moderate grade | Number of subjects to experience bladder spasms above moderate grade | Post-operative, approximately 4 hours | 
| Treatment for bladder spasms | Number of subjects requiring treatment for bladder spasms | Post-operative, approximately 4 hours | 
| Patient satisfaction | Assessed using a seven-point Likert scale where 1=strongly dissatisfied, 2=moderately dissatisfied, 3=slightly dissatisfied, 4=neutral, 5=slightly satisfied, 6=moderately satisfied, 7=extremely satisfied | Post-operative, approximately 4 hours |