Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The profiles of cortisol in the saliva
研究概览
简要总结
Total knee arthroplasty is a procedure that relieves pain in patients with severe symptomatic osteoarthritis, but it can be associated with postoperative pain, which hinders recovery. In the previous study, we reported evidence of increased pain in patients undergoing staged total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) as a result of the surgical injury to the first operated knee.
Magnesium sulfate is an effective analgesic adjuvant for postoperative pain. Its analgesic property seems to be associated with the regulation of calcium influx into the cells, or antagonism of N-methyl-D-aspartate receptors in the central nervous system. Additionally, magnesium is known to have an anti-inflammatory effect. Inflammatory state may accompany with pain via peripheral or central sensitization.
Recently, we reported that magnesium sulfate effectively attenuates not only postoperative pain but also increased pain intensity without serious adverse effects in the bilateral staged total knee arthroplasty. However, the exact mechanism regarding these effects of magnesium sulfate remains unclear.
In the present study, we will investigate the analgesic mechanism of magnesium sulfate via analysis of endocrine neurosteroid levels in patients undergoing bilateral staged total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo staged bilateral total knee arthroplasty
- •Spinal anesthesia
- •American Society of Anesthesiologists physical status 1 and 2
排除标准
- •Patients who undergo unilateral total knee arthroplasty
- •General anesthesia
- •Musculoskeletal disease
- •Hypermagnesemia
- •Atrioventricular block
- •Previous history of administration of calcium channel blockers
研究组 & 干预措施
Group M
Patients in the magnesium sulfate group received magnesium sulfate 50 mg/kg for 15 minutes after spinal anesthesia and then 15 mg/kg/hour by continuous intravenous infusion until the end of surgery
干预措施: Magnesium sulfate (Drug)
Group S
Patients in the saline group received the same volume of isotonic saline over the same period with magnesium infusion protocol
干预措施: Isotonic Saline (Drug)
结局指标
主要结局
The profiles of cortisol in the saliva
时间窗: From the evening (21:00) before the operation day to the morning (60 minutes after wake-up) of the operation day, for each stage of the operation
The cortisol concentrations in the saliva, at the evening before the operation (21:00\~22:00), just after wake-up in the morning of the operation day, and 30 and 60 minutes after wake-up
The profiles of dehydroepiandrosterone (DHEA) in the saliva
时间窗: From the evening (21:00) before the operation day to the morning (60 minutes after wake-up) of the operation day, for each stage of the operation
The DHEA concentrations in the saliva, at the evening before the operation (21:00\~22:00), just after wake-up in the morning of the operation day, and 30 and 60 minutes after wake-up
次要结局
- Anti-emetics(Postoperative 48 hour)
- Vomiting(Postoperative 48 hour)
- Postoperative pain(Postoperative 48 hour)
- Patient controlled analgesia (PCA)(Postoperative 48 hour)
- Nausea(Postoperative 48 hour)
研究者
Hyun-Jung Shin
Associate Professor
Seoul National University Hospital