A Randomized, Controlled Trial of Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older.
- •Undergoing a robotic prostatectomy under general anesthesia.
- •Is willing and able to provide consent to participate in the study.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Magnesium sulfate (Drug)
No magnesium
Patients in the second group will receive no magnesium.
结局指标
主要结局
Pain score
时间窗: 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.
次要结局
- Time to administration of analgesics(From awakening from anesthesia to administration of analgesic, 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)
- Number of participants who experienced nausea or vomiting(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)
- Number of patients who were discharged home(From PACU admission to discharge, up to 120 minutes postoperative)
- Pain score(120 minutes after awakening from anesthesia)
- Number of patients who were admitted to the hospital(From PACU admission to discharge, up to 120 minutes postoperative)
- Dose of opioid analgesia given(Through PACU stay, on average 2 hours)
- Pain score(60 minutes after awakening from anesthesia)