A Study of Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures

Mayo Clinic

Status and phase: Enrolling; Phase 2

Conditions: Bladder Spasms

Treatments: Drug: Magnesium; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05806996

22-006895

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Magnesium Group

Experimental group

Description:

Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery.

Treatment:

Drug: Magnesium

Placebo Group

Placebo Comparator group

Description:

Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery.

Treatment:

Drug: Placebo