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临床试验/CTRI/2024/04/065640
CTRI/2024/04/065640尚未招募不适用

Effect of Maternal BMI Fetal & newborn weight on the incidence of post spinal anaesthesia hypotension in full term Parturients undergoing elective caeserean section: A prospective observational study.

Sanjay Gandhi Postgraduate Institute Of Medical Science1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月22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
100
试验地点
1
主要终点
Assess the effect of maternal BMI,Fetal & Newborn weight on the incidence of post spinal anaesthesia hypotension in full term parturients undergoing elective ceasarean section

研究概览

简要总结

Spinal anesthesia is well tolerated , it still is associated with considerable side effect ,most common being hypotension due to sympatholysis , is occurring in upto 75% of cases,potentially endangerous to both mother and fetus. Spinal block leads to sympatholysis ,may leads to vasodialation and consequentally cause maternal hypotension , which compromise uterine blood flow and fetal circulation and cause fetal hypoxia ,bradycardia and acidosis. Incidence of hypotension in genral population 25-75% and even higher in parturient due to physiological change in pregnancy that cause compression in inferior venae cava by hypertrophic uterus and also due to collateral venous plexus in epidural space , the physiological change in epidural space result in increase pressure of cerebrospinal fluid in lumbosacral area which result in cephalod spread of local anaesthestics these case rapid onset of sympatholysis due to increase sensitivity of nerve fiber to local anaesthetics during pregnancy . Higher sensitivity of nerve fiber towards local anaesthetics and aorto cavel compression of pregnant ueterus ,are rthe main reason for the increase incidence and higher level of hypotension in pregnant women as compare to non pregnant women, Pregnant women have increase sympathetic activity as compare to parasympathetic , then sympatholytic activity may leads to higher degree of vasodialatation ,consequntally decrease venous return , cardiac preload , bradycardia nausea and vomiting in mother The Duration of hypotension play importance role than its severity , hypotension <2 minute didn,t affect neurodevlopment outcome , whereas maternal hypotension lasting >4 minute neurodevlopment in first week of life and may persist through life long. A Number of measurement and treatment are use in clinicle practice in spinal anasthesia induce hypotension as – -Preloading and coloading with colloid -Compressing of lower limb with compression stocking or bandage -Administration of optimal dose of local anasthetics -left tilt positioning - adminastration of ionotrops and vessopressure, phenylephrine is preferred which associated with lower incidence of fetal acidemia ,nausea and vomiting Thus identification of multifactor of spinal anasthesia induce hypotension. Might help to prevent them dramatic consequnces in mother and fetus. Thus through this study we observe the effect of maternal BMI fetal and newborn weight on hypotension by observe 100 sample patient 12 month in pmssy building sgpgi lucknow. After ethical comettie approval and CTRI registration.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • American Society of Anaesthesiologists status II Women of child bearing age Below 40year BMI less than 40 Height between 150-180 cm Non-laboring At term with singleton uncomplicated pregnancies With no gross comorbidities With longitudinal lie scheduled for elective caesarean delivery under spinal anaesthesia.

排除标准

  • Patient’s refusal for regional anaesthesia Women with obstetric conditions that may affect the severity of Aorto Caval compression, such as transverse lie, fetal macrosomia, uterine abnormalities (e.g.,large fibroids, bicornuate uterus) and polyhydramnios Women with a hypertensive disorder or any condition associated with autonomic neuropathy (e.g., diabetes mellitus for than 10 yrs), with renal failure, or currently smoking or with illicit drug use Those with kyphosis and scoliosis Sepsis at the site of the injection Indeterminate neurological disease Coagulopathy Increased intracranial pressure History of allergy to local anaesthetics Discopathy.

结局指标

主要结局

Assess the effect of maternal BMI,Fetal & Newborn weight on the incidence of post spinal anaesthesia hypotension in full term parturients undergoing elective ceasarean section

时间窗: Systolic and Diastolic Blood | Pressure recorded ,After spinal anaesthesia to til delivery

次要结局

  • Effect on Mean phenylephrine consumption

研究者

发起方
Sanjay Gandhi Postgraduate Institute Of Medical Science
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Aarti Agarwal

SGPGIMS LUCKNOW

研究点 (1)

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