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临床试验/NCT02253381
NCT02253381已完成不适用

Effect of Position During Spinal Anesthesia on Hemodynamic Change in Pregnant Women Undergoing Cesarean Section: Randomized Trial

Prince of Songkla University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Hypotension

研究概览

简要总结

Hypotension is the most common complications after spinal anesthesia especially in pregnant patients who undergoing cesarean section. Position during spinal anesthesia may be altering the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena cava that may decrease venous return and cardiac output. This leads to hypotension.The hypothesis is the right lateral position during spinal anesthesia in pregnant women will be had hemodynamic changing more than the left lateral position. This objective is to compare hemodynamic change between left and right lateral position during spinal anesthesia in pregnant women undergoing cesarean section.

详细描述

Study design: A randomized controlled trial

Study setting:

The study will be conducted in the operating rooms at Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand

Study period:

The total duration of participation in the randomized study is up to the operative day.

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
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Signed informed consent
  • Term pregnancy
  • Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml

排除标准

  • Contraindication for spinal anesthesia
  • Height < 150 cm.
  • Complicated pregnancy e.g. heart disease, preclampsia, eclampsia, diabetes millitus, twin, abrupt placenta, placenta pre via, and fetal distress
  • Failed spinal anesthesia

研究组 & 干预措施

Right lateral decubitus position

Active Comparator

Right lateral decubitus position during spinal anesthesia

干预措施: Right (Procedure)

Left lateral decubitus position

Active Comparator

Left lateral decubitus position during spinal anesthesia

干预措施: Left (Procedure)

结局指标

主要结局

Hypotension

时间窗: after bupivacaine injection until 15 minutes after spinal anesthesia

Systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline

次要结局

  • Apgar score at first minute and fifth minute(Child delivery at first minute and fifth minute)
  • Ephedrine consumption(intraoperative)

研究者

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

Panthila Rujirojindakul

Dr

Prince of Songkla University

研究点 (2)

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