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临床试验/CTRI/2024/03/063766
CTRI/2024/03/063766尚未招募不适用

Evaluation of perfusion index as an objective tool to assess analgesia during laparoscopic surgeries under general anaesthesia

Seth GSMC and KEMH1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月3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 compare changes in the perfusion index to pain stimulus (1st laparoscopic port insertion) & its variability to subsequent pain stimuli (2nd, 3rd & 4th laparoscopic port insertions) after intravenous administration of analgesic dose of fentanyl.

研究概览

简要总结

Anaesthesia is a state of analgesia, unconsciousness, and muscle paralysis.(1)

In order to broaden our knowledge on this concept, a method to quantify nociception is of the utmost importance. Quantification of nociception under anaesthesia is difficult, and therefore, reaction to nociception is used for monitoring it through increased sympathetic activity or the corresponding decreased parasympathetic stimulation (i.e. increased heart rate (HR)(2). Also, Individualized and situationally fitted intraoperative opioid administration by nociception–antinociception balance monitoring helps to avoid opioid overtreatment, opioid-induced hyperalgesia, and adverse effects and shortens the arousal time from anaesthesia.(3,4)

The perfusion index (PI) derived from a pulse oximeter is calculated as the ratio of the pulsatile blood flow to the non-pulsatile blood in peripheral tissue.(5,6) PI can be used to assess peripheral perfusion dynamics due to changes in peripheral vascular tone.(7,8,9) Perfusion index (PI) is a non-invasive and continuous measure of peripheral perfusion.(10,11,12,)The changes in sympathetic tone affect smooth muscle tone and can alter the perfusion, but are not affected by saturation and HR variability.(13-16)We aim to use this parameter to investigate its effectiveness in the assessment of analgesia to painful stimulus under anaesthesia.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • ASA class l and class ll Planned for laparoscopic surgeries under general anesthesia.

排除标准

  • Patients refusing to participate in the study Pregnant females Neurological and psychiatric diseases Chronic pain disorders,peripheral vascular disorders,ischaemic hearts disorders.
  • Autonomic dysfunction or drugs affecting the autonomic system.

结局指标

主要结局

To compare changes in the perfusion index to pain stimulus (1st laparoscopic port insertion) & its variability to subsequent pain stimuli (2nd, 3rd & 4th laparoscopic port insertions) after intravenous administration of analgesic dose of fentanyl.

时间窗: 1st laparoscopic port insertion | 2nd laparoscopic port insertion | 3rd laparoscopic port insertion | Every minute up to first 10 minutes followed by every five minutes up to 30 minutes

次要结局

  • To compare corresponding changes in perfusion index with dynamic parameters like pulse rate, non invasive blood pressure, mean arterial pressure & oxygen Saturation(1st ,2nd ,3rd ,4th laparoscopic port insertions)

研究者

发起方
Seth GSMC and KEMH
申办方类型
Research institution and hospital

研究点 (1)

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