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临床试验/CTRI/2025/08/092848
CTRI/2025/08/092848尚未招募不适用

Perfusion Index and Pleth Variability Index as Non-Invasive Predictors of Hypotension Following Spinal Anaesthesia in Lower Segment Caesarean Section: A Prospective Observational Study

Dr Subasri1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年8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
132
试验地点
1
主要终点
Quantify the incidence of hypotension following spinal anaesthesia in parturients undergoing LSCS.

研究概览

简要总结

This prospective observational study investigates whether Perfusion Index  PI and Pleth variability index PVI  can predict hypotension following spinal anaesthesia in women undergoing elective caesarean section . In 132 parturients baseline and post spinal PI PVI and hemodynamic changes monitored . The study aims to estabilish PI and PVI as non invasive predictors of post spinal hypotension and correlate them with vasopressor requirement.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Day(s) 至 40.00 Day(s)(—)
性别
Female

入选标准

  • Parturients posted for elective caesarean section under spinal anesthesia.
  • Age group 20-40 years.
  • Belongs to ASA class II and III (American society of Anaesthesiologists).

排除标准

  • contraindication to spinal anaesthesia class II obese cerebrovascular disease peripheral vascular disease cardiovascular disease.

结局指标

主要结局

Quantify the incidence of hypotension following spinal anaesthesia in parturients undergoing LSCS.

时间窗: Baseline immediately after the procedure as 0 minute,then at 1minute 3minutes6 minutes 9 minutes 12 minutes 15 minutes 25 minutes 35 minutes 45 minutes

Identify baseline PI and PVI values associated with post –spinal hypotension.

时间窗: Baseline immediately after the procedure as 0 minute,then at 1minute 3minutes6 minutes 9 minutes 12 minutes 15 minutes 25 minutes 35 minutes 45 minutes

Establish cutoff values of PI and PVI for predicting hypotension with good sensitivity and specificity.

时间窗: Baseline immediately after the procedure as 0 minute,then at 1minute 3minutes6 minutes 9 minutes 12 minutes 15 minutes 25 minutes 35 minutes 45 minutes

Enable early detection of high risk patients prone for post-spinal hypotension using non-invasive pulse oximetry.

时间窗: Baseline immediately after the procedure as 0 minute,then at 1minute 3minutes6 minutes 9 minutes 12 minutes 15 minutes 25 minutes 35 minutes 45 minutes

次要结局

  • Improve maternal & fetal outcomes by guiding individualized preventive interventions.(Support the use of PI & PVI as practical ,bedside clinical tool in obstetric anaesthesia.)

研究者

发起方
Dr Subasri
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr Subasri S

Sri Venkateshwaraa Medical College Hospital and Research Centre

研究点 (1)

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