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临床试验/CTRI/2024/10/075658
CTRI/2024/10/075658招募中不适用

Correlation between perfusion index and Bispectral index for depth of anaesthesia monitoring in adult patients undergoing elective surgery under General Anaesthesia: An Observational Study

Dr Roshan Andleeb1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
To determine the correlation between perfusion index (PI) and Bispectral Index (BIS) during anaesthesia, and to compare the predictive accuracy of PI and BIS for anaesthesia depth monitoring

研究概览

简要总结

The BiSpectral Index (BiS) is commonly used to monitor the depth of anaesthesia. The Perfusion Index (PI), a non-invasive measure of peripheral perfusion available in modern pulse oximeters, has been studied as a potential alternative for anaesthesia depth monitoring. This study aims to evaluate PI’s validity as a substitute for BiS in adult patients during general anaesthesia.  In this study, forty ASA I-II patients, aged 18-50 years of either gender, undergoing elective surgery under general anaesthesia will be recruited. Only surgical procedures with short operative durations, minimal tissue trauma, and minimal intraoperative fluid shifts will be included. General anaesthesia will be administered as per protocol. The perfusion index and BiSpectral index will be recorded simultaneously at different timestamps during the intraoperative period (before induction, after induction, after intubation, at the start of surgery, and then every 30 minutes during the surgery, at the end of the surgery, at the cessation of anaesthesia and emergence, and lastly, after extubation). The correlation between BIS and PI will be assessed using the Pearson correlation coefficient, and the predictive value of PI concerning the depth of anaesthesia will be evaluated using the ROC curve and its corresponding Area Under the Curve (AUC) analysis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • ASA I-II patients of either sex
  • Age 18-50 years
  • Patients undergoing elective surgery under general anaesthesia.
  • Surgical procedures with short operative times, minimal tissue trauma, and minimal intraoperative fluid shift
  • body mass index (BMI) 18–39 kg/m2.

排除标准

  • Patients with allergies to anaesthesia drugs
  • Patient with peripheral vascular disease, significant cardiac, renal, pulmonary, hepatic, neurological and cerebrovascular disease.
  • Patients with a history of brain injury
  • Patients on psychiatric medication.

结局指标

主要结局

To determine the correlation between perfusion index (PI) and Bispectral Index (BIS) during anaesthesia, and to compare the predictive accuracy of PI and BIS for anaesthesia depth monitoring

时间窗: intraoperative period

次要结局

  • To evaluate the association between PI and hemodynamic parameters during anaesthesia.(To evaluate the correlation between PI and the MAC value during anaesthesia)

研究者

发起方
Dr Roshan Andleeb
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Roshan Andleeb

AIIMS Kalyani

研究点 (1)

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