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临床试验/NCT02487355
NCT02487355Unknown2 期

Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries

Assiut University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
120
试验地点
1
主要终点
Time to first analgesic requirement

研究概览

简要总结

The study will conduct to compare the efficacy of Magnesium sulphate & dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients.

详细描述

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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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy male and female children, ASA I and II,Aged 6 months to 6 years, , undergoing elective surgical procedures expected to last more than 90 min, and scheduled to receive general anesthesia combined with caudal extradural block

排除标准

  • Allergy to local anesthetics,coagulation disorders, infection at site of injection, anatomic abnormalities and congenital anomalies like spina bifid, ASA III or higher, Parental refusal and the current use of Calcium Channel Blockers or Medication that may affect the neurologic system

研究组 & 干预措施

group (MG)

Active Comparator

Magnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine

干预措施: Magnesium Sulphate (Drug)

group (D)

Active Comparator

Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine

干预措施: Dexmedetomidine (Drug)

group (MD)

Active Comparator

50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine

干预措施: Dexmedetomidine + Magnesium Sulphate + Bupivacaine (Drug)

group (C)

Active Comparator

1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Time to first analgesic requirement

时间窗: 24 hours

The time from end of surgery to the first requirement of postoperative analgesia

次要结局

  • Postoperative sedation scores(24 hours)

研究者

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

jehan ahmed sayed

Associate Professor (Anesthesiology and Critical Care)- College of Medicine

Assiut University

研究点 (1)

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