Magnesium Sulfate for Prostate Surgery

Overseen By Mark Nunnally, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Disqualifiers: End-stage renal disease, allergy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether magnesium sulfate (also known as Epsom salt) can reduce pain for those undergoing prostate surgery. Participants will receive either magnesium sulfate or no magnesium during surgery to compare pain levels and recovery. The goal is to determine if magnesium results in less pain, reduced opioid use, less post-surgery shivering, and improved readiness for discharge. This trial suits individuals undergoing robotic prostate surgery who can give consent and do not have kidney failure or a magnesium allergy. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for magnesium sulfate?

Studies have shown that magnesium sulfate used during surgery can help lower blood pressure and reduce stress. It might also lessen the need for strong painkillers. Research indicates that magnesium sulfate is generally well-tolerated. In one study, patients who received magnesium sulfate during prostate surgery experienced less shivering afterward.

Magnesium sulfate is already used in hospitals for other treatments, giving it a good safety record. These studies reported no major side effects, suggesting it is safe for use during surgeries like the one in this trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using magnesium sulfate in prostate surgery because it could offer unique benefits. Unlike standard pain management options like opioids and NSAIDs, magnesium sulfate acts as a muscle relaxant and has anti-inflammatory properties, which might help reduce postoperative pain and improve recovery. Additionally, it's administered intravenously as a quick bolus at the end of surgery, potentially offering immediate effects without the side effects commonly associated with traditional pain relief drugs. This could make the surgical recovery process smoother and more comfortable for patients.

What evidence suggests that magnesium sulfate might be an effective treatment for pain management in prostate surgery?

This trial will compare the effects of magnesium sulfate with no magnesium during prostate surgery. Studies have shown that magnesium sulfate can reduce pain during such procedures. Research indicates that administering magnesium through an IV during surgery can lower blood pressure and stress hormone levels, potentially reducing the need for opioids, which are strong painkillers. Additionally, magnesium sulfate can prevent shivering after surgery, a common side effect. Overall, these benefits suggest that magnesium sulfate can smooth recovery and reduce discomfort for patients undergoing prostate surgery. ^{1 4 5 6 7}

Who Is on the Research Team?

Mark E. Nunnally, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals undergoing prostate surgery who are interested in potentially reducing their pain with magnesium sulfate as an additional pain reliever. Participants must meet certain health criteria to be eligible.

Inclusion Criteria

Is willing and able to provide consent to participate in the study

I am scheduled for a robotic surgery to remove my prostate.

Exclusion Criteria

Known allergy to magnesium sulfate preparations

I am under 18 years old.

Any patient that the investigators feel cannot comply with all study related procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo prostate surgery with or without magnesium sulfate as an adjunctive analgesic

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain scores, opioid requirements, and neuromuscular blockade reversal

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Sulfate

Trial Overview The study tests if adding magnesium sulfate to the usual anesthesia during prostate surgery can lower pain levels, reduce the need for other opioids, lessen shivering after surgery, and help patients recover better.

How Is the Trial Designed?

Group I: Magnesium Experimental Treatment 1 Intervention

Patients in the first group will receive 2 grams magnesium sulfate at the end of surgery as a bolus over approximately 10 minutes intravenously.

Group II: No magnesium Active Control 1 Intervention

Patients in the second group will receive no magnesium.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Prophylactic use of hypertonic saline (HS) during transurethral resection of the prostate (TURP) significantly reduces the incidence of TURP syndrome compared to normal saline, with only five cases reported in the normal saline group.

A low dose of 2 mL.kg-1.h-1 of hypertonic saline was effective in preventing complications without causing adverse effects like hypernatremia, making it a safer option than higher doses or normal saline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylaxis versus Treatment against Transurethral Resection of Prostate Syndrome: The Role of Hypertonic Saline. Seif, NE., Shehab, HA., Elbadawy, AM.[2023]

Kystosol irrigation during transurethral prostatic resection led to acidosis in half of the patients, while only 4 out of 27 patients in the glycine group experienced a slight decline in base excess, indicating a safer profile for glycine.

The risk of acidosis was found to increase with the volume of irrigation fluid used and the duration of the surgery, highlighting the importance of monitoring these factors during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of Kystosol and glycine as irrigating solutions during transurethral prostatic resection. Lehtonen, T.[2013]

Two patients experienced hyperchloremic metabolic acidosis and isotonic hypervolemia during thulium laser enucleation of the prostate (ThuLEP), leading to extended ventilation, intensive care, and longer hospital stays.

The study suggests that using balanced electrolyte solutions instead of normal saline during urological procedures could help prevent these complications, highlighting the need for changes in fluid management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complications from normal saline in thulium laser enucleation of the prostate]. Graß, K., Ghitulescu, A., Geldner, G., et al.[2022]

Bipolar plasma-kinetic transurethral resection of the prostate (PKRP) is a safe and effective surgical option for patients with benign prostatic hyperplasia (BPH) who are taking low-dose aspirin, as shown in a study of patients treated from November 2018 to May 2020.

The study found no significant differences in complications between patients taking aspirin and those who were not, although the aspirin group had a longer operative time and a shorter hospital stay, indicating that PKRP can be performed safely even in patients on anticoagulant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Bipolar Plasma-Kinetic Transurethral Resection of The Prostate in Patients Taking Low-Dose Aspirin. Wu, J., Li, H., Tao, R., et al.[2023]

Transurethral resection in physiological salt solution (TRPSS) was performed on 788 patients, demonstrating its efficacy in treating various lower urinary tract and prostatic gland diseases, especially in patients where traditional transurethral resection was contraindicated.

The use of isotonic salt solution during TRPSS significantly reduced complications like dilution hyponatremia and TUR syndrome, allowing for safer and longer resection times to maximize tissue removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transurethral resection in physiological salt solution]. Sevriukov, FA.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11380422/

Intraoperative magnesium sulfate is not associated with ... Univariate data suggests that patients benefitted most from Mg infusion if the procedural intervention directly involved the detrusor muscle, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33611742/

Beneficial Effects of Intravenous Magnesium Administration ... Intravenous magnesium administration during robotic radical prostatectomy reduces the increases in arterial pressure, cortisol concentrations, opioid ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06477133/magnesium-sulfate-as-an-adjunctive-analgesic-in-prostate-surgery

Magnesium Sulfate as an Adjunctive Analgesic in Prostate ... The purpose of this clinical trial is to determine if receiving magnesium sulfate as an adjunctive analgesic for prostate surgery is effective in reducing pain.

4. researchgate.net researchgate.net/publication/43182579_Magnesium_sulfate_infusion_prevents_shivering_during_transurethral_prostatectomy_with_spinal_anesthesia_A_randomized_double-blinded_controlled_study

Magnesium sulfate infusion prevents shivering during ... Our study demonstrated that the IV magnesium sulphate 50 mg/kg bolus is able to prevent shivering post-SAB and lower the incidence of high-grade ...

5. mdpi.com mdpi.com/2077-0383/8/12/2231

Effects of Perioperative Magnesium Sulfate Administration ... We showed that perioperative magnesium sulfate administration was associated with a lower rate of PPP one year after TKA. Our results suggest that magnesium ...

6. perioperativemedicinejournal.biomedcentral.com perioperativemedicinejournal.biomedcentral.com/articles/10.1186/s13741-024-00448-x

Intraoperative magnesium sulfate is not associated with ... Intraoperative magnesium sulfate is not associated with improved pain control after urologic procedures | Perioperative Medicine | Full Text.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11021848/

Magnesium Sulfate and Its Versatility in Anesthesia MgSO4's adaptable qualities present a viable path for improving anesthetic outcomes, possibly improving patient safety and improving surgical ...