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临床试验/NCT03393988
NCT03393988Unknown4 期

A Pilot Study for a Prospective, Randomized Controlled Trial of Techniques for Perioperative Analgesia for Live Liver Donors

Ain Shams University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年12月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
20
试验地点
1
主要终点
Total fentanyl consumption

研究概览

简要总结

This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesia (ASA) physical status I or II
  • Scheduled as live liver donors
  • J-shaped incision in the supraumblical region

排除标准

  • Patients with a history of psychiatric/neurological illness,
  • Hypertensive patients,
  • Morbidly obese patients,
  • Pregnant and nursing women,
  • Patients with known allergic reaction to any of the study medications,
  • Patients on recent use of sedatives or analgesics,
  • Patients with significant laboratory abnormalities

研究组 & 干预措施

Group F

Active Comparator

Fentanyl infusion (0.5 µg/kg/hr)

干预措施: Fentanyl infusion (Drug)

Group (TAP-Dex)

Active Comparator

Ultrasound guided TAP block and Dexmedetomidine

  • Ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine
  • Dexmedetomidine infusion(200 µg in 2 ml diluted in 48 ml of saline)
  • Fentanyl infusion (0.5 µg/kg/hr).

干预措施: Fentanyl infusion (Drug)

Group (TAP-Dex)

Active Comparator

Ultrasound guided TAP block and Dexmedetomidine

  • Ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine
  • Dexmedetomidine infusion(200 µg in 2 ml diluted in 48 ml of saline)
  • Fentanyl infusion (0.5 µg/kg/hr).

干预措施: Ultrasound guided TAP block (Procedure)

Group (TAP-Dex)

Active Comparator

Ultrasound guided TAP block and Dexmedetomidine

  • Ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine
  • Dexmedetomidine infusion(200 µg in 2 ml diluted in 48 ml of saline)
  • Fentanyl infusion (0.5 µg/kg/hr).

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Total fentanyl consumption

时间窗: Intraoperative

Total Intravenous fentanyl consumption during the operation

次要结局

  • Average sevoflurane concentration(Intraoperative)
  • The severity of postoperative nausea and vomiting (PONV)(First 24 hours postoperatively)
  • Ramsay sedation score (RSS)(First 24 hours postoperatively)

研究者

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

Rasha Samir Abd-ElWahab Bondok

Professor

Ain Shams University

研究点 (1)

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