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临床试验/NCT02979405
NCT02979405已完成4 期

Effectivenes of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery: a Randomised Controlled Trial

Universidad Industrial de Santander1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年1月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
140
试验地点
1
主要终点
Hypotension

研究概览

简要总结

Hypotension in patients who are taken to surgery, is a very frequent complication, when the spinal anesthetical technique is used, associating this with significant adverse effects that can lead to morbidity specially in the obstetric patient. The objective of the study is determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance of hypotension in obstetric patients led to Caesarea under spinal anesthesia.

详细描述

Worldwide, the caesarean section is one of the surgical procedures most frequently performed, representing a challenge to the anesthesiologist, who must administer anesthesia to the mother with minimal effects in the newborn. For this reason, spinal anesthesia emerges as an important option in the management of the obstetrical patient who is going to be taken to Caesarea. The hypotension, is one of the most frequent events adverse associated to this technical anesthetic, represented a risk of complications both, in the mother as in the fetus, by this reason the anesthesiologist must implement different strategies to treat it when this be present. From there arises the necessity of establishing if the phenylephrine, a drug used to treat hypotension, when is administed prophylactically, allows to avoid this effect. We designed a randomized clinical trial in elderly patients over 18 years who are taken to Caesarea, where they formed two groups of patients, one that will administer a prophylactic infusion of phenylephrine compared with placebo, assessing the incidence of hypotension in the two groups and the adverse events most commonly associated with this.

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
Double (Participant, Care Provider)

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

  • pregnant subjects who are to be delivered to cesarean section under subarachnoid anesthesia
  • Gestational age >37 weeks

排除标准

  • Pregnant subjects with:
  • Hipertensive disorders in pregnancy
  • Acute fetal distress
  • Evidence of placental dysfunction
  • History of cardiovascular or cerebrovascular diseases
  • hypersensitivity to phenylephrine
  • Rejection of the patient

研究组 & 干预措施

group 1

Experimental

Phenylephrine 40 mcg/min, infusion during 5 minutes

干预措施: Phenylephrine (Drug)

group 2

Placebo Comparator

Saline solution 21 cc, infusion during 5 minutes

干预措施: Phenylephrine (Drug)

结局指标

主要结局

Hypotension

时间窗: caesarean delivery

次要结局

  • heart rate(caesarean delivery)
  • Newborn APGAR(Turn off of the newly born: measured to the 1 and 5 minutes from the birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nelly Johanna Puentes Vega

Principal investigator

Universidad Industrial de Santander

研究点 (1)

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