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临床试验/NCT02151305
NCT02151305已完成不适用

The Influence of Propofol and Sevoflurane on Hemostasis During Ophthalmic Surgery: Rotational Thromboelastographic Study.

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2010年8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
66
试验地点
1
主要终点
Clotting time of ROTEM

研究概览

简要总结

We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patient scheduled for ophthalmic surgery under general anesthesia
  • American Society of Anesthesiologist physical status I or II

排除标准

  • hematologic disorder
  • severe anemia
  • liver disease
  • kidney disease
  • taking a medication interfering with hemostasis

研究组 & 干预措施

Total intravenous anesthesia group

Experimental

This group received propofol and remifentanil for the maintenance of general anesthesia.

干预措施: Propofol, remifentanil (Drug)

Inhalation anesthesia group

Experimental

This group received sevoflurane for the maintenance of general anesthesia.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Clotting time of ROTEM

时间窗: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia

Clot firmness time of ROTEM

时间窗: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia

Alpha angle of ROTEM

时间窗: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia

Maximum clot firmness of ROTEM

时间窗: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia

次要结局

  • Hemoglobin(10 minutes before the induction of anesthesia)
  • Hematocrit(10 minutes before the induction of anesthesia)
  • Platelet count(10 minutes before the induction of anesthesia)
  • International normalized ratio of prothrombin time(10 minutes before the induction of anesthesia)
  • Activated partial thromboplastin time(10 minutes before the induction of anesthesia)
  • Fibrinogen(10 minutes before the induction of anesthesia)

研究者

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

Hyo-Seok Na

Pf

Seoul National University Bundang Hospital

研究点 (1)

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