Postoperative Sedation After Cardiac Surgery: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Level of sedation
研究概览
简要总结
This pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •consent for participation
- •cardiac surgical procedure requiring postoperative sedation
排除标准
- •pregnant women,
- •neurological or muscular disorder
- •high risk of revision surgery
- •patients having required a redo operation if the postoperative period of sedation was less than 2 hours
研究组 & 干预措施
Automated postoperative sedation
Postoperative sedation is provided automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 40 and 60.
干预措施: Automated postoperative sedation (Device)
Automated postoperative sedation
Postoperative sedation is provided automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 40 and 60.
干预措施: propofol (Drug)
Automated postoperative sedation
Postoperative sedation is provided automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 40 and 60.
干预措施: remifentanil (Drug)
结局指标
主要结局
Level of sedation
时间窗: 6 hours
Richmond Agitation-Sedation Scale measured until extubation
次要结局
- Total amounts of propofol observed during sedation period(6 hours)
- Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning(6 hours)
- Changes in concentration of propofol consecutive to a tracheal suctioning(6 hours)
- Level of pain during sedation(6 hours)
- Changes in hemodynamics profile consecutive to a tracheal suctioning(6 hours)
- Changes in Bispectral Index consecutive to a tracheal suctioning(6 hours)
- Changes in Behavioral Pain Scale consecutive to a tracheal suctioning(6 hours)
- Changes in concentration of remifentanil consecutive to a tracheal suctioning(6 hours)
- Calculation of indices of performance of the closed-loop system(6 hours)
- Pain after extubation(6 hours)
- Delay before awakening(6 hours)
- Number of temporary or definitive interruptions of the automated administration of propofol and remifentanil(6 hours)
- Total amounts of remifentanil observed during sedation period(6 hours)
- Changes in calculated plasma concentrations of propofol including minimum concentrations and maximum values(6 hours)
- Changes in calculated plasma concentrations of remifentanil including minimum concentrations and maximum values.(6 hours)
- Hemodynamic status during the sedation period(6 hours)
- Level of consciousness after extubation(6 hours)
- Periods of electrical silence(6 hours)
- Awareness standardized questionnaire(48 hours)