Injection Speed of Spinal Anaesthesia for Asian Women Undergoing Lower Segmental Caesarean Section and the Incidence of Hypotension and/or Use of Vasopressors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
Slow Speed
Slow group patients will receive spinal injection over 60 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine.
干预措施: Slow Speed of spinal injection (Procedure)
Fast Speed
Fast group patients will receive spinal injection over 15 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine.
干预措施: Fast Speed of spinal injection (Procedure)
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
Dr. Chiang CF
Medical Officer
Ministry of Health, Malaysia