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

Trial Summary

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.

How does magnesium sulfate differ from other treatments for prostate surgery?

Magnesium sulfate may offer a unique approach to prostate surgery by potentially reducing complications like the obturator nerve reflex, which is a common issue with other surgical methods. Unlike traditional treatments that use saline solutions, magnesium sulfate might provide a different mechanism of action or benefit, although specific details are not provided in the available research. ^{1 2 3 4 5}

What is the purpose of this trial?

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. Subjects will be randomized to receive magnesium or not receive it, as part of a standardized general anesthetic for prostate surgery. The primary objective is to demonstrate improved pain scores in patients receiving magnesium sulfate as an adjunctive analgesic during surgery. Secondary objectives include demonstrating reduced requirements for other opioids, reduced postoperative shivering, improved discharge home and adequate neuromuscular blockade reversal, measured by quantitative train of four monitoring.

Research Team

Mark E. Nunnally, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Prophylaxis versus Treatment against Transurethral Resection of Prostate Syndrome: The Role of Hypertonic Saline. [2023]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Transurethral resection in physiological salt solution]. [2012]

3. Finland pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

[Complications from normal saline in thulium laser enucleation of the prostate]. [2022]

5. Iran pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Bipolar Plasma-Kinetic Transurethral Resection of The Prostate in Patients Taking Low-Dose Aspirin. [2023]