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临床试验/NCT00622791
NCT00622791已完成不适用

Effects of Cardiopulmonary Bypass on Plasma Propofol Concentrations and Bis Values During Coronary Surgery

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Propofol pharmacodynamics and pharmacokinetics

研究概览

简要总结

Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to several drugs, including propofol. Few studies, however, have tested if propofol pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic effect of propofol after CPB. This study was designed to test the hypothesis that changes in the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced by changes in bispectral index (BIS) values.

Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1) CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood samples for plasma propofol concentration measurements will be collected along the surgery and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral index values and propofol PK will be compared between the groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Isolated coronary artery bypass indication
  • Left ventricular ejection fraction greater than 50 %
  • Absence of preoperative pulmonary dysfunction

排除标准

  • Intra and postoperative circulatory shock
  • Postoperative pulmonary dysfunction

结局指标

主要结局

Propofol pharmacodynamics and pharmacokinetics

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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