Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery

NCT ID: NCT06477133

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-04

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Magnesium sulfate

Intervention Type DRUG

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

No magnesium

Patients in the second group will receive no magnesium.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Magnesium sulfate

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark E. Nunnally, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mark Nunnally, MD

Role: CONTACT

212-263-2087

Other Identifiers

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24-00463

Identifier Type: -

Identifier Source: org_study_id

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