Prostatectomy
Conditions
Keywords
Prostate surgery, analgesia
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.
Interventions
DRUGMagnesium sulfate
Pre-mixed solution of 2 grams of magnesium sulfate dissolved in 20 mL sterile water
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who received analgesics in the post anesthesia care unit (PACU) | Through PACU stay, on average 2 hours | — |
| Time to administration of analgesics | From awakening from anesthesia to administration of analgesic, up to 120 minutes postoperative | — |
| Pain score | 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. |
| Number of participants who experienced nausea or vomiting | Up to 120 minutes after awakening from anesthesia | — |
| Dose of opioid analgesia given | Through PACU stay, on average 2 hours | Dose of opioid analgesia given will be measured in milligram morphine equivalents |
| Number of patients who were admitted to the hospital | From PACU admission to discharge, up to 120 minutes postoperative | — |
| Number of patients who were discharged home | From PACU admission to discharge, up to 120 minutes postoperative | — |
| Number of participants who experienced postoperative shivering | Up to 120 minutes after awakening from anesthesia | — |
| Train-of-four (TOF) ratio | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMark E. Nunnally, MD
NYU Langone Health
Outcome results
None listed