Clinical trial NCT06477133: Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
Official title: A Randomized, Controlled Trial of Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Prostatectomy
Keywords: Prostate surgery
analgesia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain score
timeFrame: 30 minutes after awakening from anesthesia
Secondary outcomes:
measure: Pain score
timeFrame: 60 minutes after awakening from anesthesia
measure: Pain score
timeFrame: 120 minutes after awakening from anesthesia
measure: Number of participants who experienced nausea or vomiting
timeFrame: Up to 120 minutes after awakening from anesthesia
measure: Number of participants who experienced postoperative shivering
timeFrame: Up to 120 minutes after awakening from anesthesia
measure: Number of participants who received analgesics in the post anesthesia care unit (PACU)
timeFrame: Through PACU stay, on average 2 hours
measure: Time to administration of analgesics
timeFrame: From awakening from anesthesia to administration of analgesic, up to 120 minutes postoperative
measure: Dose of opioid analgesia given
timeFrame: Through PACU stay, on average 2 hours
measure: Number of patients who were admitted to the hospital
timeFrame: From PACU admission to discharge, up to 120 minutes postoperative
measure: Number of patients who were discharged home
timeFrame: From PACU admission to discharge, up to 120 minutes postoperative
measure: Train-of-four (TOF) ratio
timeFrame: TOF ratios will be measured for the duration of the operation, approximately 3 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mark E. Nunnally, MD
role: PRINCIPAL_INVESTIGATOR
References: