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临床试验/NCT07703384
NCT07703384尚未招募不适用

Comparison of The Perfusion Index and The Surgical Pleth Index in Detecting The Effectiveness of Caudal Block in Pediatric Patients Undergoing Infraumbilical Surgeries Under General Anesthesia: A Prospective Observational Study

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Time to change of value of PI and SPI after caudal block

研究概览

简要总结

Caudal block is a common method of regional anesthesia. In pediatrics, it works as a supplement to general anesthesia and is a good method for control postoperative pain. By offering superior analgesia, it decreases the use for intravenous opioids, thereby reducing related adverse reactions like nausea, vomiting, and respiratory impairment. Consequently, caudal block is a safe and appropriate method for managing pain in children undergoing different types of surgery. Usually, it is given following general anesthesia in children, making a some difficulty in evaluating the block's effectiveness The success of a caudal block is traditionally predicted by hemodynamic changes in blood pressure and heart rate, although these variables are thought to be unreliable, many tests, like 'swoosh' and 'whoosh' tests, and ultrasonography, can be used to guarantee precise needle placement and enhance the probability of block success.

Other variables are sometimes used, such as laxity of the anal sphincter tone and loss of the cremasteric reflex; however under general anesthesia, their dependability is doubtful and the latter can only be used for male children . Technological developments in pulse oximeters have improved their capacity to monitor other parameters, such as the surgical pleth index (SPI) and perfusion index (PI).

Perfusion index (PI) is a non-invasive numerical evaluation of the pulsatile strength at a monitoring site that offers helpful data regarding the patient's peripheral perfusion status .

Local vasoconstriction may induce a decrease in PI, whereas vasodilatation causes an increase in PI in the skin at the monitoring site Successful anesthesia onset is indicated by an increase in PI, but failure to do so may be indicated by a lack of increase.

Surgical pleth index (SPI) is another noninvasive, dimensionless score whose value is derived from pulse wave amplitude and heartbeat interval as measured by a pulse oximetry probe The sympathetic reaction of the patient to the surgical stimulus is reflected in SPI , research on SPI indicates that adults with values between 20 and 50 have good nociception, but its usefulness in children is unclear.

The aim of this study This study aims to determine the time to change of value of PI and SPI in assessing the effectiveness of a caudal block in pediatric patients during infraumbilical surgeries under general anesthesia

详细描述

This prospective observational study, will be conducted in Fayoum University hospital after the local Institutional Ethics Committee and local institutional review board approval.

Inclusion criteria

  • Children aged 1 to 6 years of either sex
  • With American Society of Anesthesiologists (ASA) physical status I-II
  • undergoing elective infraumbilical surgery. Exclusion criteria
  • parental refusal
  • Patients with liver disease (e.g. elevated bilirubin >2mg/dL, albumin<3.0g/dL)
  • Patients with renal disease (e.g. serum creatinine >1.5-2mg/dL)
  • Cardiac disorders (low EF>50%, sever valvular heart disease)
  • Recent respiratory tract infection within 1-2 weeks and bronchial asthma
  • Known organic brain disease (cerebral palsy, tumors)
  • patients with any contraindication to caudal anesthesia (local infection, coagulation abnormality e.g. INR > 1.5, known structural abnormality e.g. kyphosis)
  • Known allergy to local anesthetics. Anesthesia procedure Children will be assessed for enrollment the day before surgery. After enrollment, written informed consent will be obtained from the patient's parents. Children will be fasted according to standard nil per oral (NPO) guidelines: Solids and infant feeds will be withheld for 6 hours, breast milk for 4 hours, and clear fluids for 2 hours before surgery.

There will be three observers in the study: Observer 1 will be a postgraduate in anesthesia and the principal investigator, responsible for screening patients preoperatively to ensure they met the inclusion criteria and will not have any of the exclusion criteria. Observer 2 will be a consultant anesthetist who will administer the anesthesia, Observer 3 will be a postgraduate in anesthesiology who will be unaware of whether the caudal epidural working. Observer 3 will assess the analgesia and the caudal site postoperatively.

An appropriately sized intravenous (IV) peripheral line (22G or 24G) will be secured in the ward, and IV antibiotics will be administered 1 hour before the procedure, all children will undergo routine preoperative preparations by taking full history, general examination and doing investigations: Complete blood count, Coagulation profile, liver and kidney function tests All patients will receive midazolam premedication 0.05 mg/kg (IV) in the preoperative holding area. On shifting to the operating room, standard monitors including electrocardiogram (ECG)monitoring (Lead II and V5), non invasive blood pressure (NIBP), pulse oximetry (SpO2), end tidal carbon dioxide (ETCO2), and volatile anesthetic monitoring will be instituted. NIBP cuff will be attached on the arm opposite to the side of intravenous access in all the patients. The core temperature will be monitored using a nasopharyngeal probe in all the patients and will be maintained between 36.5 and 37.5°C. All these parameters and PI will be recorded by putting pulse oximeter on big toe using Nihon Kohden (Life Scope model BSM-3562, Tokyo, Japan), PI is calculated as (AC × 100/DC%), which is the ratio of infrared light absorbed by pulsing arterial flow (AC) to non-pulsatile signals in blood and tissues (DC). Its range is wide, ranging from 0.02 to 20.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • • Children aged 1 to 6 years of either sex
  • With American Society of Anesthesiologists (ASA) physical status I-II
  • undergoing elective infraumbilical surgery

排除标准

  • • parental refusal
  • Patients with liver disease (e.g. elevated bilirubin >2mg/dL, albumin<3.0g/dL)
  • Patients with renal disease (e.g. serum creatinine >1.5-2mg/dL)
  • Cardiac disorders (low EF>50%, sever valvular heart disease)
  • Recent respiratory tract infection within 1-2 weeks and bronchial asthma
  • Known organic brain disease (cerebral palsy, tumors)
  • patients with any contraindication to caudal anesthesia (local infection, coagulation abnormality e.g. INR > 1.5, known structural abnormality e.g. kyphosis)
  • Known allergy to local anesthetics

研究组 & 干预措施

Children aged 1 to 6 years of either sex With ASA I-II undergoing elective infra umbilical surgery.

Children aged 1 to 6 years of either sex With ASA I-II undergoing elective infra umbilical surgery .will receive caudal block

干预措施: caudal block (Procedure)

结局指标

主要结局

Time to change of value of PI and SPI after caudal block

时间窗: every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes

The primary outcome is the difference in time to change between the Perfusion Index (PI) and the Surgical Pleth Index (SPI) following caudal block

次要结局

  • The recorded values of PI, SPI, HR and MAP(at baseline after induction just before caudal then every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes)
  • ROC curve of PI, SPI, HR and MAP(every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes)
  • AUC of PI, SPI, HR and MAP(every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes)
  • Best cut of value of PI, SPI, HR and MAP(every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes)
  • Sensitivity and specificity of PI, SPI, HR and MAP(every minute for 10 minutes after caudal block as well as at skin incision then every 5 minutes for 30 minutes)

研究者

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

Safaa Gaber Ragab

Associate Professor of Anesthesiology

Fayoum University Hospital

研究点 (1)

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