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NCT Number: NCT06477133

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostatectomy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Magnesium sulfate

Drug

Pre-mixed solution of 2 grams of magnesium sulfate dissolved in 20 mL sterile water

Primary outcomes

  1. Pain score

    Time frame: 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 outcomes

  1. Pain score

    Time frame: 60 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.

  2. Pain score

    Time frame: 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.

  3. Number of participants who experienced nausea or vomiting

    Time frame: Up to 120 minutes after awakening from anesthesia

  4. Number of participants who experienced postoperative shivering

    Time frame: Up to 120 minutes after awakening from anesthesia

  5. Number of participants who received analgesics in the post anesthesia care unit (PACU)

    Time frame: Through PACU stay, on average 2 hours

  6. Time to administration of analgesics

    Time frame: From awakening from anesthesia to administration of analgesic, up to 120 minutes postoperative

  7. Dose of opioid analgesia given

    Time frame: Through PACU stay, on average 2 hours

    Dose of opioid analgesia given will be measured in milligram morphine equivalents

  8. Number of patients who were admitted to the hospital

    Time frame: From PACU admission to discharge, up to 120 minutes postoperative

  9. Number of patients who were discharged home

    Time frame: From PACU admission to discharge, up to 120 minutes postoperative

  10. Train-of-four (TOF) ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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