EUCTR2007-006065-32-FR进行中（未招募）1 期
Evaluation of the efficacy of 6% hydroxyethyl starch (HES, 130/0.4) in normal saline compared to Ringer’s lactate solution for the prevention of hypotension during spinal anaesthesia for caesarean section - Caesar
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Women undergoing elective caesarean section applying spinal anaesthesia
- •2.Women = week 37 of gestation
- •3.Singleton pregnancy
- •4.Age = 18 years
- •5.ASA I or II
- •6.Women in good health
- •7.Body weight = 60 kg and = 95 kg
- •8.Willingness to participate as indicated by a written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Contraindication to spinal anaesthesia
- •2.Suspicion of any hypertensive disease
- •3.Diabetes mellitus
- •4.Heart disease
- •5.History of coagulation disorders
- •6.Parturient in labour
- •7.Signs or symptoms of foetal distress
- •8.Women carrying a foetus with a known abnormality
- •9.Any other volume substitution than study medication prior induction of spinal anaesthesia
- •10.Fluid overload (hyperhydration), especially in case of pulmonary oedema and congestive cardiac failure
- •11.Renal failure with oliguria or anuria
- •12. Hyperkalaemia
- •13. Hypercalcemia
- •14. Alkalosis
- •15.Patients receiving dialyses treatment
- •16.Intracranial bleeding
- •17.Known or suspected hypersensitivity to the study medication
- •18.Known contraindication against scheduled concomitant medication
- •19.Participation in another clinical study within the last four weeks
- •20.Patients with psychiatric diseases, epilepsy
- •21.Suspicion of drug- or alcohol abuse
- •22.Patients unable to co-operate adequately
研究者
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