Magnesium and Postoperative Pain
The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Pain After Total Knee Arthroplasty in Patients Sedated With Dexmedetomidine Under Spinal Anesthesia: A Randomized-controlled Trial
With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in particular, has been increasing with the growing demand for improved mobility and quality of life. Total knee arthroplasty is performed on patients with advanced and painful osteoarthritis of the knees, but it can result in moderate to severe postoperative pain during the recovery period.
To relieve anxiety or stress during surgery under regional anesthesia, sedation can be provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor agonist, and its analgesic effect has been well established in various procedures or surgeries.
Magnesium has been reported to produce important analgesic effects including the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this study, investigators will evaluate the reducing effect of magnesium on the post-total knee arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Seongnam-si、大韩民国、13620
- Seoul National University Bundang Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients who undergo total knee arthroplasty under spinal anesthesia
- Patients who want to sedation during the surgery
- American Society of Anesthesiologists physical status classification 1 and 2
Exclusion Criteria:
- General anesthesia
- Patients who do not want to sedation during the surgery
- Patients who do not receive patient controlled analgesia postoperatively
- Muscular disease
- Hypermagnesemia
- Atrioventricular block
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：Saline
Patient who received normal saline during the operation
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Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.
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实验性的：Magnesium
Patient who received magnesium sulfate during the operation
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Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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患者自控镇痛（PCA）
大体时间：术后24小时
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PCA 消耗量
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术后24小时
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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恶心
大体时间：术后24小时
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恶心的发生率
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术后24小时
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呕吐
大体时间：术后24小时
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呕吐的发生率
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术后24小时
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Numerical rating scale
大体时间：Postoperative 24 hour
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Postoperative pain score
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Postoperative 24 hour
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Rescue analgesics
大体时间：Postoperative 24 hour
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Amounts of the analgesics administered to mange the postoperative pain
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Postoperative 24 hour
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Antiemetics
大体时间：Postoperative 24 hour
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Amounts of antiemetics consumption
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Postoperative 24 hour
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合作者和调查者
调查人员
- 首席研究员：Hyun-Jung Shin, MD, PhD、Seoul National University Bundang Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
右美托咪定的临床试验
Normal saline的临床试验
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Julphar Gulf Pharmaceutical IndustriesParexel; Profil Institut für Stoffwechselforschung GmbH完全的