跳至主要内容
临床试验/NCT04990635
NCT04990635Unknown不适用

Investigation of the Correlation of Block Success With Perfusion Index Measurement in Pediatric Surgery Performed Under Caudal Epidural Block Anesthesia"

MEHMET DURAN1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年8月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
MEHMET DURAN
入组人数
55
试验地点
1
主要终点
DISPLAYING CAUDAL BLOCK SUCCESS BY PERFUSION INDEX IN PEDIATRIC PATIENT GROUP

研究概览

简要总结

Caudal epidural anesthesia was reported as the first epidural anesthesia technique in 1933, but its use started to become widespread after the 1960s(1). The procedure is safe, easy to apply, has a low incidence of complications, and the total complication rate is 1.5/1000; serious complications are 1/40000 (2,3). There are many methods to demonstrate the success of caudal epidural block. Some of the usual traditional methods are changes in mean arterial pressure, heart rate and cremasteric reflex. These methods are sometimes not objective, but take time. In this study, we will examine whether the success of the block in pediatric patients who underwent caudal epidural block, which is applied in our hospital, is correlated with the success of the block, measured with the finger probe, other than traditional methods, and whether the perfusion index shows faster block success than other traditional methods.

详细描述

A successful caudal epidural block can provide safe, effective regional anesthesia(4). The overall failure rate of caudal epidural block in pediatric patients is approximately 4% according to the anatomical and developmental abnormalities of the caudal canal(1,5). Therefore, reliable and rapid evaluation of a successful caudal epidural block is important to optimize anesthesia management in pediatric patients. Evaluating the success of the caudal epidural block with traditional methods such as mean arterial pressure(MAP), heart rate and cremaster reflex is completely objective.

The aim of this study is to evaluate whether it will detect the success of caudal epidural block faster than other traditional methods in pediatric patients who underwent surgery with caudal epidural block, using perfusion index values measured with a finger probe.

This research; It is a prospective observational study. In our pediatric patients who routinely underwent caudal epidural block under sedation in our hospital, perfusion index values will be recorded by attaching a probe to the big toe. Perfusion index(PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow.(6) PI works by measuring the changes in finger peripheral perfusion through pulse oximetry.(7) If the procedure is successful in patients who underwent caudal epidural block, there is an increase in perfusion in the lower extremities due to sympathetic nerve blockade. Therefore, in our study, we will observe whether perfusion increases by measuring the perfusion index value measured using a finger probe, by attaching the probe to the big toe, before the caudal epidural block is performed and at the 1,5, 7, 10, 15 and 20 minutes after the caudal epidural block. Simultaneously, the mean arterial pressure, heart rate and changes will be recorded by looking at the cremaster reflex in male patients. The finding that shows the presence of the cremaster reflex is to hit the upper inner part of the thigh and to pull the scrotum and testis on the same side. A 15% decrease in pulse rate and an increase in the perfusion index value indicate a successful caudal epidural block. We will examine whether the increase in the perfusion index after these procedures is correlated with the success of the block, and whether the perfusion index shows a faster block success than other traditional methods.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • lower abdomen/urogenital/lower extremity surgery
  • PEDIATRIC GROUP BETWEEN 1-6 YEARS
  • Patients with ASA1-2

排除标准

  • Neuromuscular disease
  • PATIENTS WITH ASA3-4
  • Patients with cerebral palsy
  • Patients with mental retardation
  • Patients with hematological disorders
  • Infection in the region to be caudal block

结局指标

主要结局

DISPLAYING CAUDAL BLOCK SUCCESS BY PERFUSION INDEX IN PEDIATRIC PATIENT GROUP

时间窗: PATIENTS PIERFUSION INDEX, PULSE AND TENSION MEASUREMENTS 1.5,7,10,15,20 MINUTES AFTER THE CAUDAL BLOCK IS MADE

CORRELATION OF CAUDAL BLOCK SUCCESS WITH PERFUSION INDEX VALUE WILL BE EVALUATED APPLICABLE TO SEDATATIZED PEDIATRIC PATIENTS IN LOWER ABONE SURGERIES

次要结局

未报告次要终点

研究者

发起方
MEHMET DURAN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

MEHMET DURAN

MDURAN

Adiyaman University

研究点 (1)

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