Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery

Phase 4

Recruiting

• Conditions: Prostatectomy
• Interventions: Drug: Magnesium sulfate

• Registration Number: NCT06477133
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-04
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-06-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States