Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil
试验速览
- 阶段
- 不适用
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- The onset time
研究概览
简要总结
The participants: 1800 full-term primiparas will be selected with ASA I-Ⅱgrade, 20 to 35 years old and weighing 55 to 90 kg in the investigator's hospital from may 2018 to December 2018. 1200 primiparas were divided into A and B according to the computer randomized numbers, and 600 parturients without labor analgesia in the same period were selected as group C, with 600 patients in each group. All parturients signed the informed consent form and were approved by the hospital ethics Committee.
详细描述
1200 primiparas were divided into A and B according to the computer randomized numbers, and 600 parturients without labor analgesia in the same period were selected as group C, with 600 patients in each group. All parturients signed the informed consent form and were approved by the hospital ethics Committee.
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 (Investigator)
入排标准
- 年龄范围
- 22 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I-Ⅱ, aged 22 - 42,
- •gestational age ≥ 37, weight 55 - 90 kg,
- •labor analgesia is required by full-term primiparas.
排除标准
- •serious cardiovascular and cerebrovascular system diseases,
- •bradycardia, conduction block
- •fetal distress
- •contraindications of intraspinal anesthesia.
研究组 & 干预措施
dexmedetomidine ropivacaine
Observing 0.5 μ g / ml dexmedetomidine + 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
干预措施: Dexmedetomidine ropivacaine (Drug)
dexmedetomidine ropivacaine
Observing 0.5 μ g / ml dexmedetomidine + 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
干预措施: No analgesia labor (Drug)
sufentanil ropivacaine
compare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor.
干预措施: Dexmedetomidine ropivacaine (Drug)
sufentanil ropivacaine
compare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor.
干预措施: No analgesia labor (Drug)
No analgesia labor
Observing with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
干预措施: Dexmedetomidine ropivacaine (Drug)
No analgesia labor
Observing with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
干预措施: No analgesia labor (Drug)
结局指标
主要结局
The onset time
时间窗: 30 minutes
A drug's effects to come to prominence upon administration.
次要结局
- analgesic effect(1 day)
研究者
Zeyong Yang
Department of Anesthesiology, Principal Investigator, Clinical Professor,International Peace Maternity and Child Hospital
Shanghai Jiao Tong University School of Medicine