Correlation of Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Occurrence of restless leg syndrome
研究概览
简要总结
The restless leg syndromes is a common sensorimotor disorder of unknown cause affecting approximately 10% of the population. Different literature had different views on the association between neuraxial anesthesia and the occurrence of restless leg syndrome. Some reported that spinal anesthesia induced postoperative restless leg syndrome, but other studies showed that spinal and general anesthesia all two did not cause restless leg syndrome. A potential difference amongst these studies is that a big difference exists in surgical types. The investigators proposed that different types of surgery performed undergoing various anesthesia, and that there is a big difference in original pathophysiological condition. Therefore, the investigators hypothesized that pregnant women who have special physical states would have had an association between neuraxial anesthesia and restless leg syndrome in such patients who received selective cesarean section undergoing spinal or epidural anesthesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnancy
- •Selective cesarean
- •Gestational age >= 37 weeks
排除标准
- •Allergic to local anesthetics
- •Allergic to opioids
- •History of psychosis
- •Cognition malfunction
- •Any organic diseases
- •Original lower extremity dyskinesia and paraesthesia
- •Chronic pain
- •Difficult in sleep
- •Drug and alcohol abuse
结局指标
主要结局
Occurrence of restless leg syndrome
时间窗: One day to one week after completion of cesarean
次要结局
- Intraoperative anesthetic effectiveness(From the beginning of anesthesia (0 min) to completion of cesarean (45 min))
- Postoperative analgesic effectiveness(From the initiation of analgesia (0 min) to 48 h after cesarean)
- Other postoperative side effects: hypotension, pruritus, nausea, vomiting, distal paraesthesia, dyskinesia in lower extremity(From the completion of cesarean (1 day) to one week follow-up)
- Psychological state(From one day to one week follow-up after cesarean)
- Infant weight(Three min after cesarean section)
- One-min Apgar score(One min after cesarean section)
- Five-min Apgar score(Five min after cesarean section)
- Intraoperative vital signs(From the beginning of cesarean (0 min) to completion of operation (45 min))