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临床试验/CTRI/2024/05/066787
CTRI/2024/05/066787招募中4 期

Comparison of phenylephrine requirements to treat post-spinal hypotension in early onset and late onset preeclampsia patients undergoing caesarean section – An analytical experimental study

University College of Medical Sciences and Guru Teg Bahadur Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
74
试验地点
1
主要终点
Total phenylephrine requirements

研究概览

简要总结

Spinal anaesthesia will be administered with hyperbaric 0.5% bupivacaine with 10 microg fentanyl. Hypotension after spinal anaesthesia will be defined as a fall of systolic blood pressure of 20% or more from baseline. Phenylephrine bolus of 50 microg will be administered to treat every hypotensive blood pressure value. Umbilical arterial and venous blood samples of the fetus will be obtained for blood gas analysis. After the procedure, on the basis of history from the patient/relatives and discussion with the obstetrician, the patient will be allocated to either early or late onset preeclampsia group. The total phenylephrine requirements, maternal haemodynamic variables, number of hypotensive episodes, incidence of reactive hypertension and bradycardia, neonatal Apgar scores, fetal acid-base status and maternal complications will be recorded.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Preeclamptic females with singleton pregnancy of 34 weeks gestation or more undergoing caesarean section under spinal anaesthesia.

排除标准

  • Maternal complications other than preeclampsia such as chronic hypertension, other cardiovascular disease, cerebrovascular disease
  • Multiple gestation
  • Eclampsia
  • Known fetal abnormality
  • Patients with absolute or relative contra-indications for spinal anaesthesia
  • Severe fetal distress or other conditions requiring immediate induction of general anaesthesia.

结局指标

主要结局

Total phenylephrine requirements

时间窗: From the time of administration of spinal anaesthesia to the time of delivery of baby

次要结局

  • 1. Maternal haemodynamic variables(2. Total number of hypotensive episodes)

研究者

发起方
University College of Medical Sciences and Guru Teg Bahadur Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Medha Mohta

University College of Medical Sciences and Guru Teg Bahadur Hospital

研究点 (1)

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