A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

Phase 2RecruitingNCT05806996

Mayo Clinic120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Bladder Spasms

Interventions

MagnesiumDRUG

Intravenous infusion, load 50 mg/Kg with infusion of 15 mg/Kg/hour

PlaceboDRUG

Equivalent volume of normal saline

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Minnesota

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of bladder spasm

Number of subjects to experience bladder spasms

Time frame: Post-operative, approximately 1 hour

Secondary Outcomes

Incidence of bladder spasm above moderate grade

Number of subjects to experience bladder spasms above moderate grade

Time frame: Post-operative, approximately 4 hours

Treatment for bladder spasms

Number of subjects requiring treatment for bladder spasms

Time frame: 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

Time frame: Post-operative, approximately 4 hours

Central Contacts

Tami Krpata

CONTACT

507-422-5768 krpata.tami@mayo.edu

Data from ClinicalTrials.gov

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