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临床试验/NCT06162806
NCT06162806已完成不适用

Evaluation of Adding Magnesium Sulfate to (Fentanyl/Bupivacaine)Bi-mixture as an Adjuvant to Local Anesthesia in Caudal Block Among Pediatrics in Lower Abdominal Urological Surgeries. a Prospective Randomized Comparative Study

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
time to first requirement of rescue analgesia

研究概览

简要总结

this is a randomized controlled study ,patients will be randomly divided into 2 groups , Group A will receive caudal block using 1ml/kg Bupivacaine +0.5u/kg fentanyl, Group B will receive caudal block 50 mg magnesium sulfate added to (1ml/kg Bupivacaine +0.5u/kg fentanyl)

详细描述

A total of 50 pediatric patients undergoing lower abdominal urological surgeries will be enrolled in this prospective randomized controlled (RCT) study.

I- Randomization:

All included subjects will be randomly allocated and will be divided into two groups; (Group A): will receive [Fentanyl / Bupivacaine], and (Group B): will receive magnesium sulfate added to the previous bi-mixture [Fentanyl / Bupivacaine]. Using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique. There will be no restrictions or stratification in the randomization process. The allocation envelope will be opened by the assistant lecturer at the time of anesthetic preparation. Also, the drug preparation will be conducted by an anesthetist who will not involve in any of the study collection data. Finally, the data will be analyzed on an intention-to-treat basis and included all patients who were randomly assigned.

II- Study protocol

  1. Pre-operative preparation All children will be anaesthetized in accordance with the local policy of the Abou El-Resh pediatric hospital-Cairo University's pediatric anesthetic unit. Except for oral clear fluid intake 2 hours before surgery, all children will fast for 6 hours. Patients will attend in the preparation room one hour before the operation to get a preoperative checkup, their age and body weight will be recorded as well.
  2. Intra-operative management

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •pediatric patients aging from 2-12 years
  • •undergoing lower abdominal urological surgeries not exceeding 3 hours
  • •ASA I and II

排除标准

  • •parents refusal to participate in the study
  • •deformities in the spine
  • •coagulopathy
  • •localized infection at site of needle insertion
  • •known allergic to any of the used drugs

研究组 & 干预措施

Group A

Active Comparator

This group of patients will receive ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine +0.5ulkg fentanyl

干预措施: ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl (Procedure)

Group B

Experimental

This group of patients will receive ultrasound guided caudal epidural block with 50 mg of magnesium added to (1ml/kg Bupivacaine+0.5ulkg fentanyl)bi-mixture

干预措施: ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl) (Procedure)

结局指标

主要结局

time to first requirement of rescue analgesia

时间窗: 24 hours

the time after the operation when the patient need rescue analgesia

次要结局

  • complications(24 hours)
  • postoperative opioid analgesia consumption(24 hours)

研究者

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

Abd elmoneim Adel Abd elmoneim

clinical professor

Cairo University

研究点 (1)

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