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临床试验/CTRI/2025/06/089870
CTRI/2025/06/089870尚未招募不适用

Efficacy of inferior vena cava compressibility index in predicting post spinal hypotension and its correlation with perfusion index and pleth variability index in infraumbilical studies

GMC Amritsar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月7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
To assess the correlations of Inferior Vena Cava compressibility index (IVC

研究概览

简要总结

Spinal anaesthesia is the most common modality for patients undergoing infraumbilical surgeries. Hypotension is the most common complication, which can be avoided by early prediction of fluid status of the patients and optimizing it. The present study was  conducted in the Department of Anaesthesia and Intensive care, Government medical college, Amritsar after approval from institutional thesis and ethics committee. 100 patients will be randomized into 2 groups of 50 each on the basis of inferior vena cava compressibility index noted using ultrasound before giving spinal anaesthesia with a cutoff of 40%. Group A with inferior vena cava compressibility index <40% and Group B inferior vena cava compressibility index >40%. Spinal anaesthesia will be administered to all patients and co-loading will be done with ringer lactate. Haemodynamic monitoring of heart rate, diastolic blood pressure, systolic blood pressure, mean arterial pressure, peripheral oxygen saturation (spo2), and electrocardiography along with perfusion index and pleth variability index will be done. The primary objective of the study will be to assess the efficacy of inferior vena cava compressibility index with hypotension and its sensitivity and specificity in predicting hypotension. Secondary objectives will be total amount of  doses of vasopressor used, side effects and complications and to see the correlation of perfusion index and pleth variability index with inferior vena cava compressibility index in predicting hypotension.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American society of anaesthesiology (ASA) GRADE I-II Elective infraumbilical surgeries under spinal anaesthesia.

排除标准

  • Total number doses of vasopressor given to treat hypotension.
  • Correlation of Perfusion index and Pleth variability index with hypotension.
  • Any side effects and complications.

结局指标

主要结局

To assess the correlations of Inferior Vena Cava compressibility index (IVC

时间窗: baseline ,followed by every 1 minute till 10 minutes,than every 5 minutes till 40 minutes ,followed by every 10 minutes till 60 minute

CI) with hypotension.

时间窗: baseline ,followed by every 1 minute till 10 minutes,than every 5 minutes till 40 minutes ,followed by every 10 minutes till 60 minute

To calculate sensitivity and specificity of Inferior Vena Cava compressibility

时间窗: baseline ,followed by every 1 minute till 10 minutes,than every 5 minutes till 40 minutes ,followed by every 10 minutes till 60 minute

index in predicting hypotension.

时间窗: baseline ,followed by every 1 minute till 10 minutes,than every 5 minutes till 40 minutes ,followed by every 10 minutes till 60 minute

次要结局

  • Total number of doses of vasopressor given to treat(hypotension.)

研究者

发起方
GMC Amritsar
申办方类型
Government medical college

研究点 (1)

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