Hemodynamic Effects of Supine Position Versus Left Lateral Tilted Position During Cesarean Delivery: a Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- postspinal hypotension
研究概览
简要总结
In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position
详细描述
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Aortocaval compression is one of the theoretical mechanisms precipitating for post-spinal hypotension (PSH) for CD. Positioning of the patients in the left lateral tilted position after preforming spinal block was frequently considered a standard protocol for minimizing aortocaval compression and improve maternal hemodynamics during CD; however, the latest Cochrane database review reported that there is no adequate evidence to support any positioning protocol for prevention of PSH. Moreover, a recent study was conducted in full term pregnant women reporting no improvement in cardiac output with left lateral tilting. In this study, the effect of left lateral tiling performed after spinal block on maternal hemodynamics will be compared to ordinary supine position.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •full term
- •singleton pregnant women
- •scheduled for elective cesarean delivery
排除标准
- •Cardiac morbidities
- •hypertensive disorders of pregnancy
- •peripartum bleeding
- •baseline systolic blood pressure (SBP) < 100 mmHg
- •body mass index > 35
研究组 & 干预措施
supine position
the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position
干预措施: supine position (Other)
supine position
the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in supine position
干预措施: Bupivacaine (Drug)
Left lateral tilted position
the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position
干预措施: left lateral tilted position (Other)
Left lateral tilted position
the patient will receive spinal anesthesia by Bupivacaine; then she will be placed in left lateral tilted position
干预措施: Bupivacaine (Drug)
结局指标
主要结局
postspinal hypotension
时间窗: 30 minutes after spinal anesthesia
The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
次要结局
- severe postspinal hypotension(30 minutes after spinal anesthesia)
- Post-delivery hypotension(10 minutes after delivery)
- systolic blood pressure(60 minutes after spinal block)
- diastolic blood pressure(60 minutes after spinal block)
- incidence of nausea and vomiting(60 minutes after spinal block)
- ephedrine consumption(60 minutes after spinal block)
- Atropine consumption(60 minutes after spinal block)
- heart rate(60 minutes after spinal block)
- APGAR score(10 minute after delivery)
研究者
Ahmed Hasanin
Assistant professor
Cairo University