NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol
研究概览
简要总结
The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton pregnancy
- •clinically indicated intrauterine transfusion
- •red cell alloimmunisation
排除标准
- •severe adipositas
- •suspicion of structural anomalies
- •fetal hydrops
- •contraindication for remifentanil
研究组 & 干预措施
remifentanil
干预措施: Remifentanil (Drug)
saline
干预措施: saline (Drug)
结局指标
主要结局
evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol
时间窗: 15-60 minutes
次要结局
- influence of analgesics (remifentanil) on the fetal stress response(15-60 minutes)
