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临床试验/NCT00567957
NCT00567957Unknown4 期

Remifentanil for c-Section With General Anesthesia in Severe Preeclamptic Patients

Istanbul University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
50
试验地点
1
主要终点
Blood pressure

研究概览

简要总结

The purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section.

详细描述

General anesthesia for cesarean section involves rapid sequence induction with a muscle relaxant and barbiturate followed by endotracheal intubation. Although the use of opioids may blunt haemodynamic responses to endotracheal intubation, they are avoided in pregnant patients due to possible respiratory depressants effects on neonates.Preeclamptic patients response with exaggerated sympathoadrenal reflex to anesthesia induction and intubation. The resulting hypertension and tachycardia may result in cerebrovascular accident, pulmonary edema, arrhythmias, increased myocardial oxygen consumption and fetal hypoxia by uterine vasoconstriction. Several drugs have been used to blunt the hemodynamic disturbances to intubation, but none of them have been implicated for routine use for general anesthesia in preeclamptic patients.

Recently remifentanil has started to be used in general anesthesia of high risk obstetric patients. Remifentanil is a μ-opioid receptor agonist that is metabolized by nonspecific blood and tissue esterase hydrolysis. It has a low distribution volume with a context sensitive half life of 3 minutes. Its elimination half life is 12 minutes even after repeated boli. Previously remifentanil use in pregnant patients with cardiac pathology has been reported with minimal neonatal side effects. A randomized controlled study in normal parturient has shown that remifentanil is transferred through placenta and may cause mild neonatal depression that is easily managed. Umbilical artery and vein remifentanil concentrations has shown that remifentanil is quickly redistributed or metabolized in fetus. Thus, remifentanil may be an appropriate drug for induction and maintenance of general anesthesia in severe preeclamptic patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Severe preeclamptic parturients with single fetus pregnancy with contraindication to regional anesthesia

排除标准

  • Known allergy to study drugs
  • Known fetal anomaly and /or gestation week and /or estimated to be nonviable (fetal weight <400 gr, gestational week<24 weeks)
  • Known cardiac disease diagnosed prior to pregnancy
  • Known drug abuse in the parturient
  • Multifetal gestation
  • Anticipated difficult airway management (mask ventilation and/or endotracheal intubation).

研究组 & 干预措施

C

Placebo Comparator

Saline starting before induction till entry to abdominal cavity

干预措施: Saline (Drug)

R

Active Comparator

Remifentanil starting before induction till entry to abdominal cavity

干预措施: Remifentanil (Drug)

结局指标

主要结局

Blood pressure

时间窗: Induction to post-intubation period

次要结局

  • Heart rate(Induction to delivery)
  • Amount of additional drugs and fluids if required(Induction to delivery)
  • Evaluation of the newborn(Within 10 min following delivery)

研究者

申办方类型
Other

研究点 (1)

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