Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
研究概览
简要总结
Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of awareness, especially in the period before delivery. The investgators assessed the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
详细描述
Sixty primipara undergoing elective cesarean delivery were randomly assigned to receive remifentanil 1 μg kg-1 (R1) or 0.5 μg kg-1 (R0.5), or saline (control) over 15 s with induction of anesthesia using propofol 2 mg kg-1 and suxamethonium 1.5 mg kg-1.The investgators assessed the average value of BIS at the time period of before, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery. The investgators also determined the neonatal Apgar scores, and conducted umbilical artery blood gas analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II who elected to undergo Caesarean section, under general anaesthesia
排除标准
- •multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication
研究组 & 干预措施
Remifentanil 1 μg kg-1 (R1)
Received remifentanil 1μg/kg when induction of general anesthesia
干预措施: remifentanil (Drug)
Remifentanil 0.5 μg kg-1 (R0.5),
Received remifentanil 0.5μg/kg when induction of general anesthesia
干预措施: remifentanil (Drug)
结局指标
主要结局
the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
时间窗: the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
the average value of BIS at the time period of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
次要结局
- incidence of intraoperative awareness(one day and one week after delivery.)
研究者
Qing Zhu
attending physician
West China Second University Hospital