The efficacy of pneumatic leg compression versus leg elevation in preventing post spinal hypotension in elective cesarean section- a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- To compare the incidence of hypotension between the groups
研究概览
简要总结
The primary method of anaesthesia for caesarean section is spinal anaesthesia.
Hypotension, which is a frequent side effect of spinal anaesthesia and is due to
preganglionic sympathetic suppression, which ultimately results in vasodilatation, is one of
the major side effects. Systolic pressure reduction can affect foetal circulation and uterine
blood flow, which can lead to acidosis and hypoxia in the developing child. According to
the various studies, between 50% and 60% of caesarean sections performed under spinal
anaesthesia result in hypotension.
Due to the potentially serious consequences for both the mother and the new-born,
spinal anesthesia-induced hypotension after caesarean section must be prevented
and managed. For the management and prevention of PSH, a variety of methods
(pharmacological and physical approaches) have been tried with varying degrees of
success.
Despite being the most popular strategy for treating hypotension, pharmacological
techniques have a variety of undesirable side effects. While phenylephrine is thought to be
the preferred medication, it produces bradycardia and lowers blood supply to the placenta.
Ephedrine crosses the placenta and stimulates beta-adrenergic receptors in the foetus,
increasing foetal metabolic rate.
Leg elevation (LE) increases venous return by directing blood flow from the lower
extremities to the thorax. Therefore, LE boosts cardiac output (CO) via increasing stroke
volume (SV). In order to avoid PSH, LE is a simple, non-invasive, and
non-pharmacological method.
Intermittent pneumatic compression (IPC) of the lower extremities prevents blood from accumulating in the legs by generating circumferential compressions and decompressions
at precise pressures. They have mostly been utilised for venous thromboembolism
prevention and major urological surgery. [ 5-7] Despite this, there are few studies on the
hemodynamic effects of pneumatic leg compression during spinal anaesthesia. To the best
of our knowledge, research studies have not examined the effectiveness of pneumatic
compression and leg elevation in preventing post-spinal hypotension or spinal
anesthesia-induced hypotension following caesarean delivery. This investigation compares
the effectiveness of pneumatic compression versus leg elevation in reducing post-spinal
hypotension during caesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients posted for elective caesarean section.
排除标准
- •Patients who do not consent to participate in the study
- •Patients with contraindications for spinal anaesthesia
- •Patients with contraindications for the use of pneumatic compressions like serious arterial insufficiency, deep venous thrombosis, presence of localized wound infection or cellulitis, etc
- •Patients with gestational hypertension, preeclampsia, eclampsia
- •Patients converted to general anaesthesia due to inadequate sensory blockade from spinal anaesthesia.
结局指标
主要结局
To compare the incidence of hypotension between the groups
时间窗: Till the delivery of baby
次要结局
- 1. To compare the requirement of a rescue dose of phenylephrine(2. To compare the number of rescue doses of phenylephrine)
研究者
Dr Avasarala Katyayani Vidmahi
All India Institute of Medical Sciences, Jodhpur
