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临床试验/NCT03328299
NCT03328299已完成2 期

Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block for Patient Undergoing Lower Abdominal Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年11月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
24
试验地点
1
主要终点
measure dexmedetomidine level into systemic circulation after local administration

研究概览

简要总结

TAP-block has been shown to be a safe and effective postoperative analgesia method in a variety of general. Dexmedetomidine is a selective α2 agonist with 8 times more affinity for α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist without respiratory depression. Dexmedetomidine has been focus of interest for its broad spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 24 ASA I-II
  • patients (age 18-60 years
  • weight 50-89 kg

排除标准

  • a known allergy to the study drugs
  • significant cardiac
  • respiratory, renal or hepatic diseases
  • bleeding diathesis

研究组 & 干预措施

Dexmedetomidine group

Active Comparator

patients were given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine + dexmedetomidine 1 μg•kg-1 diluted in 20 ml saline

干预措施: Dexmedetomidine (Drug)

bupivacaine group

Placebo Comparator

patients will given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine

干预措施: bupivacaine (Drug)

结局指标

主要结局

measure dexmedetomidine level into systemic circulation after local administration

时间窗: up to 6 hours

assessment of systemic dexmedetomidine level after local administration in TAP block after 15 minutes after giving the block, 30 min, 45 min, 1hrs, 2hrs, 4hrs and 6

次要结局

  • total dose of IV PCA morphine consumption in the first 24 h postoperative(24 hours)

研究者

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

Fatma Adel El sherif,MD

lecturer of anesthesia , ICU and pain management

Assiut University

研究点 (1)

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