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临床试验/NCT02275897
NCT02275897已完成不适用

Injection Speed of Spinal Anaesthesia for Asian Women Undergoing Lower Segmental Caesarean Section and the Incidence of Hypotension and/or Use of Vasopressors

Ministry of Health, Malaysia2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
2
主要终点
Incidence of Hypotension

研究概览

简要总结

The purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus.

详细描述

We plan to investigate if by varying the speed of injection during spinal anaesthesia, will there be a difference in the incidence of hypotension. Hypotension is a common complication especially for pregnant women undergoing caesarean section. A high speed of injection can theoretically cause a higher spread of anaesthetic, which may increase the incidence of hypotension. We want to know if by prolonging the injection time, will this lead to a reduction in a rate of hypotension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • at least 18 years of age
  • singleton term pregnancy
  • American Society of Anesthesiologists (ASA) class I-II

排除标准

  • Severe pre-eclampsia
  • contraindications to spinal anaesthesia
  • Height <150cm or >180cm
  • Weight ≥100kg
  • Baseline systolic BP <90 mmHg
  • Baseline systolic BP >150mmHg
  • Category 1 urgency for delivery

结局指标

主要结局

Incidence of Hypotension

时间窗: First 10 minutes after injection

How many patients will experience a drop in systolic Blood Pressure of greater than 20%

次要结局

  • Use of vasoconstrictors(First 10 minutes after injection)
  • Adequacy of block(Time of surgery)

研究者

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

Dr. Chiang CF

Medical Officer

Ministry of Health, Malaysia

研究点 (2)

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