Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery

A Randomized, Controlled Trial of Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostatectomy
• Intervention / Treatment: Drug: Magnesium sulfate

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 and older.
2. Undergoing a robotic prostatectomy under general anesthesia.
3. Is willing and able to provide consent to participate in the study.

Exclusion Criteria:

1. Patients younger than 18 years
2. Patients with end-stage renal disease
3. Known allergy to magnesium sulfate preparations
4. Any patient that the investigators feel cannot comply with all study related procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnesium; Patients in the first group will receive 2 grams magnesium sulfate at the end of surgery as a bolus over approximately 10 minutes intravenously.	Drug: Magnesium sulfate; Pre-mixed solution of 2 grams of magnesium sulfate dissolved in 20 mL sterile water
No Intervention: No magnesium; Patients in the second group will receive no magnesium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Patients will be asked to assess their pain based on a 10-point scale, where 0=no pain and 10=worst imaginable pain.	30 minutes after awakening from anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Patients will be asked to assess their pain based on a 10-point scale, where 0=no pain and 10=worst imaginable pain.	60 minutes after awakening from anesthesia
Pain score	Patients will be asked to assess their pain based on a 10-point scale, where 0=no pain and 10=worst imaginable pain.	120 minutes after awakening from anesthesia
Number of participants who experienced nausea or vomiting		Up to 120 minutes after awakening from anesthesia
Number of participants who experienced postoperative shivering		Up to 120 minutes after awakening from anesthesia
Number of participants who received analgesics in the post anesthesia care unit (PACU)		Through PACU stay, on average 2 hours
Time to administration of analgesics		From awakening from anesthesia to administration of analgesic, up to 120 minutes postoperative
Dose of opioid analgesia given	Dose of opioid analgesia given will be measured in milligram morphine equivalents	Through PACU stay, on average 2 hours
Number of patients who were admitted to the hospital		From PACU admission to discharge, up to 120 minutes postoperative
Number of patients who were discharged home		From PACU admission to discharge, up to 120 minutes postoperative
Train-of-four (TOF) ratio	Train- of-four ratio (TOF) is the ratio of the fourth muscle response to the first one.	TOF ratios will be measured for the duration of the operation, approximately 3 hours

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mark E. Nunnally, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: analgesia; Prostate surgery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Sulfur Compounds; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Magnesium Compounds; Magnesium Sulfate
• Other Study ID Numbers: 24-00463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research, provided the investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided). The protocol, Statistical Analysis Plan, and Informed Consent Form will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes