Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
A Randomized, Controlled Trial of Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2024
CompletedFirst Submitted
Initial submission to the registry
June 20, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
March 5, 2026
March 1, 2026
2 years
June 20, 2024
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Pain score
60 minutes after awakening from anesthesia
Pain score
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
- +5 more secondary outcomes
Study Arms (2)
Magnesium
EXPERIMENTALPatients in the first group will receive 2 grams magnesium sulfate at the end of surgery as a bolus over approximately 10 minutes intravenously.
No magnesium
NO INTERVENTIONPatients in the second group will receive no magnesium.
Interventions
Pre-mixed solution of 2 grams of magnesium sulfate dissolved in 20 mL sterile water
Eligibility Criteria
You may qualify if:
- Age 18 and older.
- Undergoing a robotic prostatectomy under general anesthesia.
- Is willing and able to provide consent to participate in the study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark E. Nunnally, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2024
First Posted
June 27, 2024
Study Start
June 4, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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).
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