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临床试验/CTRI/2025/03/082042
CTRI/2025/03/082042尚未招募不适用

Evaluation of role of perfusion index as a predictor of post subarachnoid block hypotension in geriatric patients A prospective observational study

CMS Vineesha1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月1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
50
试验地点
1
主要终点
To predict hypotension after spinal anaesthesia with baseline perfusion index

研究概览

简要总结

Hypotension is common in elderly patients for surgery under spinal anaesthesia with an incidence of over 50%. Old age is one of main risk factors for  development of hypotension during spinal anaesthesia. The main cause of hypotension is sympathetic block with associated decrease in systemic vascular resistance. The response is exaggerated in elderly due to negative influence of a relatively higher resting sympathetic tone and decreased baroreceptor activity leading to a higher incidence of hypotension. Geriatric patients may have difficulty tolerating the negative effects of hypotension and this may lead to an increased incidence of complications. Therefore, careful consideration and monitoring are essential when using spinal anaesthesia in elderly patients, especially those with pre-existing comorbidities

Non-invasive blood pressure (NIBP) measurement is the established approach for monitoring intraoperative hemodynamic. The perfusion index is a ratio calculated with pulsatile light absorption over continuous light absorption and gives information about vascular tone and volume status with data obtained from pulse oximeter which is part of a standard anaesthesia monitor. The perfusion index (PI) is defined as the ratio of pulsatile blood flow to non-pulsatile blood flow in the peripheral vascular tissue. It is assessed using a pulse oximeter that measures amount of Infrared light absorbed. The PI serves to evaluate perfusion dynamics and is being considered as a non-invasive means to predict likelihood of hypotension development.This technology was used in the fluid responsiveness in trauma and septic patients, estimating the success of regional anaesthesia, and predicting hypotension in parturient. The standard monitoring site for pulse oximetry is the fingertip, where the normal PI ranges from 0.02% to 20%.

Masimo Signal Extraction Technology (SET) pulse oximetry provides continuous and simultaneous absolute values and trends for PI, arterial oxygen saturation (SaO2), and pulse rate. These values are generated using validated signal extraction technology, which also offers associated alarms to alert medical personnel to any concerning changes in these parameters.

We have planned this study as there are scarce data available regarding efficacy of pulse oximetry-derived perfusion index as predictor of post-spinal hypotension in geriatric patients

研究设计

研究类型
Observational

入排标准

年龄范围
65.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • 1.All types of general surgical procedures mainly orthopaedic surgeries that will be conducted under spinal anaesthesia 2.American society of Anaesthesiologists (ASA) physical status I, II, III.

排除标准

  • 1.Cardiac arrhythmia 2.Digital ischemia
  • Allergic reaction to local anesthetic and opiate 4.NYHA III-IV, 5.Uncontrolled hypertension 6.Known cardiac diseases 7.Subarachanoid block above T8 level.

结局指标

主要结局

To predict hypotension after spinal anaesthesia with baseline perfusion index

时间窗: Baseline, at 60 minutes

次要结局

  • To assess relation between perfusion index and hypotension at different time intervals(Upto 60 minutes after spinal anesthesia)

研究者

发起方
CMS Vineesha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR CMS Vineesha

NIZAM INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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