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临床试验/NCT05580094
NCT05580094已完成不适用

Combined General Anesthesia and Ultrasound Guided Supraclavicular Block Versus General Anesthesia in Pediatric Patients With Chronic Kidney Disease Undergoing Upper Limb Superficialization of Arteriovenous Fistula.

Assiut University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
brachiocephalic fistula maturation time

研究概览

简要总结

  • compare the safety and efficacy of ultrasound-guided supraclavicular block in addition to general anesthesia in pediatric patients undergoing upper limb superficialization of arteriovenous fistula for hemodialysis.
  • compare the amount of analgesic consumption as well as vasodilatation of upper limb blood vessels and its implications on the vascular anastomosis.

详细描述

Established renal disease is a significant cause of morbidity and mortality in children and has implications for the conduct of general anesthesia (1).

Anesthetic management of pediatric patients is uniquely challenging. A large part of the anesthetic care includes pain management, management of concomitant disease, and risk reduction for adverse events. Perioperative pain management usually involves a multimodal pharmacologic approach to minimize opioid requirements. Regional anesthesia is valuable for postoperative pain control (2).

Postoperative analgesia is dictated by the extent and nature of the surgery. Regional block should be utilized where possible for its opioid-sparing effects. Where morphine infusions are commenced, the dose should be reduced due to the risk of accumulation of active metabolites and resultant opiate toxicity. Non-steroidal anti-inflammatory drugs are always avoided due to their deleterious effects on urine output (3).

Pediatric regional anesthesia is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anesthetic practice. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids. Upper extremity brachial plexus blocks in children Various approaches to brachial plexus are available. The choice of the block is made depending on the indications. The supra-clavicular approach covers all the surgeries of the humerus and below (4).

The use of regional anaesthesia is mostly associated with vasodilatation which may guard against arterial spasm and may play a role in decreasing the postoperative complication and success of the superficialization of the arteriovenous shunt as a line for hemodialysis.

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)

盲法说明

Double (Participant, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients of less than 18 years old.
  • with chronic kidney disease.
  • undergoing upper limb superficialization of arteriovenous fistula for haemodialysis.

排除标准

  • Patient known to have allergy to the studied drugs.
  • Patients with contraindications to regional anesthesia.

结局指标

主要结局

brachiocephalic fistula maturation time

时间窗: 6 month postoperative

time in weeks required by fistula to be clinically mature

次要结局

  • anaesthetic consumption(90 minutes intraoperative)
  • postoperative analgesia time(24 hours postoperative)
  • EMERGENCE agitation(30 minutes postoperative)
  • VAS score(24h postoperative)

研究者

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

Esraa Fathy Radwan Abd Elzaher

Resident doctor at anesthesia,icu and pain management department

Assiut University

研究点 (2)

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