Hemodynamics Effects of Left Lateral Tilt on the Full Term Pregnant Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- change in cardiac output (L/min) before anesthesia
研究概览
简要总结
The aim of the study is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after spinal anesthesia
详细描述
At operating room, patients will be monitored using non invasive blood, ECG, pulse oximeter and electrical cardiometry. Baseline readings will be taken in supine position then repeated after putting the patient in left lateral position with angle 15 then 30 degrees.
Then two IV lines will be inserted and 500cc crystalloid will be administered. Subarachnoid block will be performed in sitting position under complete aseptic conditions using 25 g spinal needle. Subarachnoid block will be achieved by injecting 10 mg hyperbaric bupivacaine plus 25 ug fentanyl. The block will be considered successful if adequate block reached T4 dermatome.
After successful block the hemodynamic variables will be recorded in the same positions as before (0,15, 30 degrees left uterine tilt).
A minimum number of 61 patients was calculated to have a study power of 80% and alpha error of 0.05.
SPSS Chicago 18 software will be used for data analysis. Categorical data will be presented as frequencies, continuous variables will presented as mean ± standard deviation and will be analyzed using on way analysis of variance (ANOVA) with post-hoc pairwise comparisons using bonferroni test. A P value of 0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •full term, singleton, American society of anesthesiologists (ASA) I and II pregnant women scheduled for cs
排除标准
- •BMI > 35 Kg/m2
- •polyhydramnios
- •history of impaired cardiac contractility
- •valvular heart disease
- •cardiac arrhythmias
- •hypertensive pregnancy disorders
- •fetal abnormalities
结局指标
主要结局
change in cardiac output (L/min) before anesthesia
时间窗: baseline : 5min after putting the patient in supine position then 1min after left uterine tilt at 15 and 30 degrees
measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).
change in cardiac output (L/min) after spinal anesthesia
时间窗: baseline after assessing adequate block reaching T4 dermatome then 1 min after left uterine tilt at 15 and 30 degrees
measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).
次要结局
- change in mean arterial blood pressure (mmHg)(baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block)
- change in systemic vascular resistance (dyn.s/cm5)(baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block)
研究者
Yasmin Hassab elnaby
Lecturer
Cairo University