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临床试验/NCT02037802
NCT02037802已完成不适用

Caudal Extradural Catheterization in Pediatric Renal Transplant: Effect on Perioperative Hemodynamics and Pain Scoring.

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Intraoperative blood pressure

研究概览

简要总结

pain control in pediatric renal transplant is a major concern. the main goal during anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to that of the adult donor. epidural analgesia is thought to be very effective in pain control. this study emphasises the ease of application of epidural catheter via the caudal route to the lower thoracic level; avoiding possible complications that may arise from lumbar or thoracic routes, and its effects on hemodynamics when using analgesic doses of local anesthetics and narcotics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

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

入选标准

  • 3-12 years
  • end stage renal disease
  • no known allergy to bupivacaine
  • both sexes

排除标准

  • known allergy to bupivacaine
  • inflammation at caudal area
  • spinal cord deformity

研究组 & 干预措施

control group

Sham Comparator

30 patients didn't receive caudal epidural analgesia

干预措施: Fentanyl (Drug)

caudal epidural catheterization group

Active Comparator

30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours

干预措施: B-Braun, Perifix® ONE Paed, Germany (Device)

caudal epidural catheterization group

Active Comparator

30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours

干预措施: Pethidine (Drug)

caudal epidural catheterization group

Active Comparator

30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours

干预措施: Propofol (Drug)

caudal epidural catheterization group

Active Comparator

30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours

干预措施: Bupivacaine (Drug)

caudal epidural catheterization group

Active Comparator

30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours

干预措施: Fentanyl (Drug)

control group

Sham Comparator

30 patients didn't receive caudal epidural analgesia

干预措施: Pethidine (Drug)

control group

Sham Comparator

30 patients didn't receive caudal epidural analgesia

干预措施: Propofol (Drug)

结局指标

主要结局

Intraoperative blood pressure

时间窗: from the induction of anesthesia till end of surgery at half an hour intervals

measure systolic and diastolic blood pressure

次要结局

  • postoperative central venous pressure(from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours)
  • postoperative blood pressure(from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours)
  • postoperative heart rate(from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours)
  • intraoperative central venous pressure(fromom the induction of anesthesia till end of surgery at half an hour intervals)
  • intraoperative heart rate(from the induction of anesthesia till end of surgery at half an hour intervals)

研究者

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

Sherif Mohamed Abd el moneim Soaida, MD

Lecturer

Cairo University

研究点 (1)

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