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临床试验/NCT04238234
NCT04238234Unknown不适用

Comparison of Ultrasound-based Measures of Inferior Vena Cava and Plethysmographic Variability Index for Prediction of Hypotension During Induction of General Anesthesia; Prospective Cohort Study.

Cairo University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年8月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Comparison of the accuracy (Area under receiver operating characteristic curves) of PVI and IVC variation in prediction of post-induction hypotension

研究概览

简要总结

This thesis aims to evaluate the ability of preoperative plethysmographic variability index to predict post-induction hypotension in comparison with ultrasound measurements of inferior vena cava (IVC) diameter.

详细描述

Prospective cohort study. Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured and routine premedications (ranitidine 50 mg and ondansteron 4mg) will be administrated.

Then inferior vena cava ultrasonography will be performed. Maximum and minimum IVC diameters over a single respiratory cycle will be measured using built-in software. The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax , it will be expressed as a percentage.

Plethysmographic variability index and a perfusion index readings will be taken preinduction in the form of three readings on one-minute interval.

Induction of anaesthesia will be achieved using propofol (2 mg/Kg) and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation.

Anaesthesia will be maintained by isoflurane (1-1.5%) and atracurium 10 mg increments every 20 minutes. Ringer lactate solution will be infused at a rate of 2 mL/Kg/hour.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>18years)
  • ASA I-II-III
  • Patients scheduled for elective surgeries under general anaesthesia.

排除标准

  • Operations which will last for less than 15 minutes.
  • Patients with cardiac morbidities (impaired contractility with ejection fraction < 40% and tight valvular lesions, unstable angina).
  • Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
  • Patient with decompansted respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation < 90% on room air).
  • Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
  • Patients with peripheral vascular disease or long standing DM affecting PVI readings.
  • Pregnancy

结局指标

主要结局

Comparison of the accuracy (Area under receiver operating characteristic curves) of PVI and IVC variation in prediction of post-induction hypotension

时间窗: 10 minutes before general anesthesia

Maximum and minimum IVC diameters over a single respiratory cycle will be measured using a built-in software. The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax CI will be expressed as a percentage

次要结局

  • Heart rate(20 minutes)
  • Mean arterial blood pressure(20 minutes)
  • Maximum and minimum IVC diameters(10 minutes)
  • Plethysmographic variability index (PVI) and a perfusion index readings (PI)(3 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bassant M. Abdelhamid

associate professor

Cairo University

研究点 (2)

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