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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Patient controlled analgesia (PCA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Saline
Patient who received normal saline during the operation
干预措施: Normal saline (Drug)
Magnesium
Patient who received magnesium sulfate during the operation
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Patient controlled analgesia (PCA)
时间窗: Postoperative 24 hour
Amounts of PCA consumption
次要结局
- Numerical rating scale(Postoperative 24 hour)
- Nausea(Postoperative 24 hour)
- Vomiting(Postoperative 24 hour)
- Rescue analgesics(Postoperative 24 hour)
- Antiemetics(Postoperative 24 hour)
研究者
Hyun-Jung Shin
Assistant Professor
Seoul National University Hospital