Tachycardia as an Indication for Prophylactic Phenylephrine Injection in Caesarean Section Under Spinal Anesthesia; an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Occurrence of Hypotension Avoidance of Hypotension Avoidance of Hypotension
研究概览
简要总结
The value of phenylephrine administration in response to tachycardia in preventing hypotension after spinal anesthesia in elective cesarean section.
详细描述
This observational study will take place at Ain Shams University Maternity hospitals, Cairo, Egypt. All patients will sign written informed consent before inclusion.
Sample size:
Using PASS 15 program for sample size calculation, setting confidence level at 95% and margin of error at 0.05, it is estimated that sample size of 80 women will be needed to detect an expected incidence rate of hypotension after phenylephrine administration of 30% "Hasanin et al., 2019"
Inclusion criteria:
ASA II pregnant female planned for elective C.S., aged between 18 -35 years old.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA II pregnant female planned for elective C.S., aged between 18 -35 years old.
排除标准
- •Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI patients with cardiovascular diseases
结局指标
主要结局
Occurrence of Hypotension Avoidance of Hypotension Avoidance of Hypotension
时间窗: all through the procedure (cesarean section)
Measure number of hypotensive episodes that would occur after injection of prophylactic phenylephrine for caesarean section ,by spinal anesthesia
次要结局
- Apgar score in neonates. Number of phenylephrine doses. Nausea & vomiting after spinal anesthesia.(all through the procedure (cesarean section))
研究者
maha sadek El Derh
Assistant professor of Anesthesia
Ain Shams University