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临床试验/NCT01013558
NCT01013558已完成1 期

NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Remifentanil (Drug)

saline

Placebo Comparator

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)

研究者

发起方
Leiden University Medical Center
申办方类型
Other

研究点 (1)

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