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临床试验/CTRI/2023/07/055498
CTRI/2023/07/055498尚未招募不适用

Comparative evaluation of Internal Jugular Vein Collapsibility Index guided versus conventional crystalloid administration on post spinal hypotension in parturients undergoing caesarean section.

Maulana Azad Medical College and Lok Nayak Hospital.1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To evaluate the incidence of post spinal hypotension

研究概览

简要总结

Spinal anaesthesia is the anaesthetic techniqueof choice for caesarean section. The most common side effect of spinal anaesthesia is hypotension and has a very high incidence rate.It is caused by spinal block induced sympatholysis which leads to vasodilation and thereby hypotension. The administration of intravenous fluids to optimise the blood volume during sympathectomy has been widely used as first line therapy. Ultrasound has been used to estimate the pre-operative intravascular volume status. Internal jugular vein is an easily accessible vessel for assessment of intravascular fluid volume .Thus, we plan to undertake this study to evaluate and compare internal jugular vein collapsibility index guided versus conventional crystalloid administration on post spinal hypotension in pregnant patients undergoing caesarean section.

The study will be conducted in the Department of Anaesthesiology, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi. In this study, pregnant patients aged between 18- 40 years scheduled for elective caesarean section will be recruited.

Primary objective of the study is to evaluate the incidence of post spinal hypotension whereas secondary objective is to evaluate the amount of crystalloid administered before spinal block, to evaluate the number of episodes of hypotension, vasopressor requirement, and total amount of fluid administered till cord clamping and to evaluate the APGAR score of the baby at 1 minute and 5 minutes.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patients of American Society of Anesthesiologists(ASA) Physical status
  • Term, singleton pregnancy
  • Height of the patient ( 150- 170) cms.

排除标准

  • Absolute contraindications for spinal anaesthesia -localized sepsis,deranged coagulation profile,severe hypovolemia, severe aortic stenosis, severe mitral stenosis.
  • Relative contraindications for spinal anaesthesia- pre existing neurological deficits, severe spinal deformity.
  • Significant hepatic, renal or cardiovascular disease.

结局指标

主要结局

To evaluate the incidence of post spinal hypotension

时间窗: BP measurement will be done every 2 minutes for the first 15 minutes after spinal anaesthesia followed by every 5 minutes till the end of surgery to assess hypotension

次要结局

  • 1. Amount of crystalloid administered before spinal block.(2.Number of episodes of hypotension)

研究者

发起方
Maulana Azad Medical College and Lok Nayak Hospital.
申办方类型
Government medical college

研究点 (1)

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