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临床试验/CTRI/2020/09/027511
CTRI/2020/09/027511尚未招募不适用

Correlation of Perfusion Index with Bispectral Index for depth of anaesthesia in children undergoing elective surgery

Department of Anaesthesiology and Critical Care1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月9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
Decrease in anaesthetic requirement with correlation to Perfusion Index

研究概览

简要总结

Perfusion Index is the ratio of pulsatile blood flow signal as percentage of non pulsatile blood flow signal. It is a non invasive, reliable and indirect representation of the peripheral perfusion and circulatory status. During general anaesthesia, peripheral vasodialation is a well known side effect and it induces changes in the amplitude of the pulse plethysmograph waveform which can be recorded using Masimo Radical-7 SET monitor as Perfusion Index and it can be compared with Bispectral Index which has been established as a method of measurement of depth of anaesthesia  for induction, maintainence as well as recovery phase. We hypothesized that the Perfusion Index would increase with the induction of general anaesthesia and decrease with emergence in children. Using PI in comparison to BIS may help in developing a useful tool for intraoperative anaesthesia monitoring and the assessment of anaesthetic depth. Although there are limited studies in literature comparing PI and BIS, so we have planned to conduct this study to compare trends of PI in correlation to BIS for depth of anaesthesia and to see changes in PI with time during general anaesthesia. The study is a prospective and observational study with a total of 50 , ASA I or II paediatric patients aged between 2-12 years of either sex scheduled for elective surgery requiring general anaesthesia in supine position.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Paediatric patients belonging to American Society of Anaesthesiologists(ASA) physical status I or II scheduled for elective surgery requiring general anaesthesia in supine position will be enrolled in this study.

排除标准

  • Patients having peripheral circulatory disorder, dyshemoglobinemia(methemoglobinemia, sickle cell anaemia, thalassemia, anaemia), neurological disorders, receiving treatment with antiepileptic medications or stimulants, pre-existing lung or cardiac disease, airway abnormalities, artificial nails, dark pigmentation over fingers or patients having contraindication to the planned anaesthesia technique will be excluded from the study.

结局指标

主要结局

Decrease in anaesthetic requirement with correlation to Perfusion Index

时间窗: baseline, 2 minutes after induction, at airway manipulation, at 5 and 10 minutes following induction of general anaesthesia, at cessation , at eye opening

次要结局

  • Correlation of Perfusion Index with Bispectral Index(at baseline, 2 minutes after induction, on airway manipulation, 5 minutes, 10 minutes after induction, cessation of anaesthetic, eye opening)

研究者

发起方
Department of Anaesthesiology and Critical Care
申办方类型
Government medical college

研究点 (1)

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