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临床试验/NCT06695520
NCT06695520尚未招募4 期

Is the Perfusion Index an Indicator for Success of Caudal Epidural Anasthesia in Pediatric Patients?

Assiut University0 个研究点目标入组 54 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
54
主要终点
changes in perfusion index.

研究概览

简要总结

A caudal epidural block is among the most widely administered techniques of regional anesthesia in pediatric patients. It helps in reducing the intraoperative dose of inhalational anesthetic agent used for maintenance of anesthesia and in addition provides an excellent postoperative analgesia without the side effects of intravenous opioid medication, like nausea and vomiting during emergence, cardiovascular, and respiratory depression. the aim of the study was to assess, perfusion index (PI) as an indicator for success of caudal block onset in pediatric patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs.

with guidance of ultrasonography.

详细描述

It is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space. Using conventional blind technique, the failure rate of caudal epidural block is high even in experienced hands. With the advent of ultrasound in guiding needle placement, the success rate of caudal epidural block has been markedly improved and could be effective in preventing complications during caudal epidural injection. After administration of a caudal block, reliable assessment of caudal block is very crucial to ascertain the success of block. The onset of caudal block is often assessed by cold stimuli and cutaneous temperature changes. Caudal block in pediatric patients is often performed under general anesthesia. Hence, testing the sensory levels by above techniques cannot be used. Also the change in the hemodynamic parameters are few other assessment methods. These methods are to be used 15-20 min after block administration, to confirm the efficacy of a caudal block. Perfusion index (PI), independent of parameters like heart rate, oxygen saturation of blood, or body temperature, measures the ratio of arterial blood flow (pulsatile flow) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and it is shown in percentage or absolute value . PI is considered as a sensitive marker to assess the efficacy of caudal block. It can detect the onset of caudal block, by increasing PI beyond the pre-induction values, which can be due to the sympathectomy induced after successful caudal administration,which increases the blood flow to the peripheral tissues.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • -ASA physical status I-II. -Both sexes -Age between 2 and 10 years -Patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs.

排除标准

  • ASA physical status more than II.
  • Patients having any neurological disorders, bleeding disorder, bony deformity of vertebral column.
  • infection at the injection site, drug allergy, and undergoing anal surgery.

结局指标

主要结局

changes in perfusion index.

时间窗: baseline

measures the ratio of arterial blood flow (pulsatile flow) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and it is shown in percentage or absolute value

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Monika Samir Melad

resident doctor at Anathesia , ICU & Pain Management

Assiut University

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Perfusion Index in Caudal Epidural Anasthesia | 临床试验