Bladder Spasms
Conditions
Brief summary
This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.
Interventions
DRUGMagnesium
Intravenous infusion, load 50 mg/Kg with infusion of 15 mg/Kg/hour
DRUGPlacebo
Equivalent volume of normal saline
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bladder spasm | Post-operative, approximately 1 hour | Number of subjects to experience bladder spasms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bladder spasm above moderate grade | Post-operative, approximately 4 hours | Number of subjects to experience bladder spasms above moderate grade |
| Treatment for bladder spasms | Post-operative, approximately 4 hours | Number of subjects requiring treatment for bladder spasms |
| Patient satisfaction | Post-operative, approximately 4 hours | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGregory Nuttall, MD
Mayo Clinic
Outcome results
None listed