ProstatectomyPhase 4NCT06477133
Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
A Phase 4 study testing Magnesium sulfate in people with Prostatectomy, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatectomy
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older.
- Undergoing a robotic prostatectomy under general anesthesia.
- Is willing and able to provide consent to participate in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prostatectomy
- Being tested
- Magnesium sulfate
- Keywords
- Prostate surgery, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Pre-mixed solution of 2 grams of magnesium sulfate dissolved in 20 mL sterile water
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Experimental | Patients in the first group will receive 2 grams magnesium sulfate at the end of surgery as a bolus over approximately 10 minutes intravenously. Receives: Drug: Magnesium sulfate |
| No magnesium | No intervention | Patients in the second group will receive no magnesium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after awakening from anesthesia
Secondary outcomes (10)
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.
Measured: 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.
Measured: 120 minutes after awakening from anesthesia
Number of participants who experienced nausea or vomiting
Measured: Up to 120 minutes after awakening from anesthesia
Number of participants who experienced postoperative shivering
Measured: Up to 120 minutes after awakening from anesthesia
Number of participants who received analgesics in the post anesthesia care unit (PACU)
Measured: Through PACU stay, on average 2 hours
Time to administration of analgesics
Measured: 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
Measured: Through PACU stay, on average 2 hours
Number of patients who were admitted to the hospital
Measured: From PACU admission to discharge, up to 120 minutes postoperative
Number of patients who were discharged home
Measured: 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.
Measured: TOF ratios will be measured for the duration of the operation, approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start4 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark E. Nunnally, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477133
- Sponsor's protocol ID
- 24-00463
- Status last verified
- Mar 2026
- First submitted
- 20 Jun 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
- ClinicalTrials.gov ID
- NCT06477133
- Acronym / sponsor ID
- 24-00463
- Conditions
- Prostatectomy
- Keywords
- Prostate surgery, analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Drug: Magnesium sulfatePatients 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 intervention | –Patients in the second group will receive no magnesium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older.
- Undergoing a robotic prostatectomy under general anesthesia.
- Is willing and able to provide consent to participate in the study.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfatePre-mixed solution of 2 grams of magnesium sulfate dissolved in 20 mL sterile water | Drug | Magnesium |
Primary outcome
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.
10 secondary outcomes
Pain score
Time frame: 60 minutes after awakening from anesthesia
Pain score
Time frame: 120 minutes after awakening from anesthesia
Number of participants who experienced nausea or vomiting
Time frame: Up to 120 minutes after awakening from anesthesia
Number of participants who experienced postoperative shivering
Time frame: Up to 120 minutes after awakening from anesthesia
Number of participants who received analgesics in the post anesthesia care unit (PACU)
Time frame: Through PACU stay, on average 2 hours
Time to administration of analgesics
Time frame: From awakening from anesthesia to administration of analgesic, up to 120 minutes postoperative
Dose of opioid analgesia given
Time frame: Through PACU stay, on average 2 hours
Number of patients who were admitted to the hospital
Time frame: From PACU admission to discharge, up to 120 minutes postoperative
Number of patients who were discharged home
Time frame: From PACU admission to discharge, up to 120 minutes postoperative
Train-of-four (TOF) ratio
Time frame: TOF ratios will be measured for the duration of the operation, approximately 3 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark E. Nunnally, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulfate in people with Prostatectomy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 30 minutes after awakening from anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.