跳至主要内容
临床试验/CTRI/2025/07/091837
CTRI/2025/07/091837尚未招募不适用

A prospective observational clinical trial to assess the efficacy of perfusion index (PI) as a predictor of onset of pediatric caudal block under general anesthesia

SINGAREDDY SUMANTH KUMAR REDDY1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2025年8月10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
77
试验地点
1
主要终点
To compare the role of PI, HR, and Mean Arterial Pressure (MAP) in detecting the onset and adequacy of caudal block.

研究概览

简要总结

Caudal block under general anesthesia is quite popular for pediatric lower limb surgeries as it is one technique that fits all. It is relatively easy to learn with a high mean success rate and a remarkable safety record. However, failure of the caudal block is about 4% due to abnormal anatomy, operator inexperience and wrong choice of block.

It is often very difficult to assess the quality of analgesia in children intra-operatively as most of the regional blocks are performed under general anesthesia or sedation in contrast to adults. Conventionally one waits to see the patient’s response to the surgical skin incision to make a clinical decision of working caudal block. Unsuccessful block causes a raise in HR, Blood Pressure on skin due to pain. This calls for more reliable and faster objective parameters that can confirm the efficacy of caudal block in children.

Recent advances in Pulse Oximeter technology have broadened the ability to measure more parameters such as Perfusion Index (PI). PI is a noninvasive numerical assessment of the pulsatile strength at a monitoring site providing useful information about the peripheral perfusion status of the patient. A decrease in PI can occur because of local vasoconstriction while vasodilatation results in an increase in PI in the skin at the monitoring site. Recent studies recommended that PI can be used as an early and sensitive indicator to detect the development of epidural-induced sympathectomy leading to vasodilation and increased perfusion in adults. In adult population many numbers of studies done and most of them concluded that PI is the best tool in predicting the onset and adequacy of caudal block. In children especially in Indian population, the studies that have been done are very limited. This study that mainly focusing on pediatric population might be helpful to assess whether PI can be applied to detect the onset and adequacy of caudal block under GA similar to adults. Hence in this study we tried to compare the role of PI, HR and Mean Arterial Pressure (MAP) in detecting the onset and adequacy of caudal block.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • ASA grade 1 and 2, undergoing infraumbilical surgeries.

排除标准

  • who are allergic to local anaesthetics, with coagulation abnormalities, spinal abnormalities, neurological deficits and infection at the site of caudal block.

结局指标

主要结局

To compare the role of PI, HR, and Mean Arterial Pressure (MAP) in detecting the onset and adequacy of caudal block.

时间窗: first 20 minutes during surgery

次要结局

  • To monitor PI trends after caudal epidural anesthesia in children(first 20 minutes during surgery)

研究者

发起方
SINGAREDDY SUMANTH KUMAR REDDY
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

SINGAREDDY SUMANTH KUMAR REDDY

Jawaharlal Nehru Medical College

研究点 (1)

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