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临床试验/NCT01569048
NCT01569048已完成4 期

Randomized Controlled Trial to Evaluate of Dexmedetomidine for the Effect on Operative Visibility in Patients Undergoing Endoscopic Sinus Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
66
试验地点
1
主要终点
surgical satisfaction about visibility of operative field

研究概览

简要总结

Various maneuvers are commonly used to achieve the ideal operative field necessary for successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during intranasal operation.

The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to remifentanil , an ultrashort-acting opioid.

研究设计

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

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 20 and 70 year
  • General anesthesia for endoscopic sinus surgery

排除标准

  • Body mass index >30
  • Congestive heart failure, Sinus Bradycardia(<50 BPM), Uncontrolled hypertension,
  • Coagulopathy
  • Drug addiction
  • Pregnancy
  • Allergic fungal infection

研究组 & 干预措施

remifentanil

Active Comparator

干预措施: propofol and remifentanil (Drug)

dexmedetomidine

Experimental

干预措施: Propofol and dexmedetomidine (Drug)

结局指标

主要结局

surgical satisfaction about visibility of operative field

时间窗: Within 1 day of endoscopic sinus surgery finish including dressing of surgical wound

subjective satisfaction about visibility of operative field by surgeon/ numerous rating scale / 0: worst - 10:best

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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