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临床试验/CTRI/2023/11/060172
CTRI/2023/11/060172招募中4 期

The efficacy of pneumatic leg compression versus leg elevation in preventing post spinal hypotension in elective cesarean section- a randomized controlled trial

All India Institute of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2023年11月30日最近更新:

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

发起方
All India Institute of Medical Sciences Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Avasarala Katyayani Vidmahi

All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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