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临床试验/CTRI/2021/08/035816
CTRI/2021/08/035816已完成不适用

Role of Internal jugular vein(IJV) collapsibility index to predict post spinal hypotension in pregnant women undergoing cesarean section, a prospective observational study.

AIIMS RAIPUR1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2021年8月27日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
试验地点
1
主要终点
IJV diameter,IJV collapsibility index, episodes of intra operative hypotension

研究概览

简要总结

Internal jugular vein (IJV) is easier to access and there is limited data and study in the aspect of IJV collapsibility index as a predictor of post spinal hypotension, especially in pregnant women. This study is aimed at evaluation of IJV collapsibility index in assessment of post-spinal hypotension in caesarean section.

Patient fulfilling inclusion criteria will be explained about the procedure and after taking consent ,patient will be included in the study. Baseline hemodynamic parameters will be noted. Patient  will be subjected to ultrasonography of the right side of neck using linear probe ,the sonographic measurements of IJV will be assessed using M mode imaging and measurements such as  depth of IJV ,relation to carotid artery, maximum diameter (at end of expiration),minimum diameter(at end of inspiration),collapsibility index will be measured. The anaesthesiologist  performing ultrasonography will not be involved in intraoperative monitoring. Patient will recieve spinal anaesthesia and sensory level of T6 is targeted .And parameter such blood pressure (SBP,DBP,MAP),HR,RR,SpO2 will be noted every 3 minutes until delivery of the baby. The fall of MAP by 20% from baseline or <65 mmHg will be considered as hypotension. Hypotension will be treated with 6mg of mephentermine or 25mcg of phenylephrine intravenously. The study will finish with delivery of the baby& cord clamping. Data collection will be stopped and number of doses of vasopressor used to counteract hypotension will be noted.

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

  • 1.Age: 18 – 40 years
  • American Society of Anaesthesiologists Physical Status II
  • Singleton pregnancy
  • Elective cesarean section under spinal anaesthesia 5.Gestational age >37 weeks.

排除标准

  • 1.Essential or pregnancy-induced hypertension.
  • 2.Diabetes including gestational diabetes.
  • 3.Heart disease.
  • 4.Abruptio placenta.
  • 5.Placenta previa 6.Premature and Over dated (<36 or >41 weeks gestation) pregnancy.
  • 7.Haemoglobin of less than 7 gm/dl.
  • 8.Hemoglobinopathies.
  • 9.Peripheral vascular disease.
  • 10.Coagulopathies.
  • 11.parturient with baseline heart rate of <50/minutes.
  • 12.Partial spinal block.

结局指标

主要结局

IJV diameter,IJV collapsibility index, episodes of intra operative hypotension

时间窗: IJV diameter and IJV collapsibility index will be measured preoperatively, Blood pressure monitoring (Systolic, diastolic and mean arterial pressures)from spinal anaesthesia every 3 minutes until delivery of the baby.

次要结局

  • Body mass index (BMI),(period of fasting, abdominal girth, boluses of vasopressor used,heart rate and SpO2)

研究者

发起方
AIIMS RAIPUR
申办方类型
Research institution and hospital

研究点 (1)

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