Performance of the Minto Model in Effect Site Mode for Target Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Median prediction error
研究概览
简要总结
Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is performed using the Minto model. It was derived from patients undergoing general surgery. However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The investigators tested whether Minto model for target controlled infusion produces constant plasma remifentanil concentration during the cardiac surgery.
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
- Double (Participant, 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
- 否
入选标准
- •Adult patients with the ASA class I~III undergoing elective cardiac surgery using cardiopulmonary bypass
排除标准
- •Patients not using target controlled infusion during the operation
- •Patients with drug/substance abuse
- •Patients using analgesics before this study starts
- •Pregnant women
- •Patients who rejected study participation
研究组 & 干预措施
Remiva
This experimental group will use a generic drug of remifentanil, Remiva™ from Hana Pharmaceutical company.
干预措施: Remiva (Drug)
Ultiva
This arm group will use a brand-named drug of remifentanil, Ultiva™ from GlaxoSmithKline company.
干预措施: Ultiva (Drug)
结局指标
主要结局
Median prediction error
时间窗: during CPB
次要结局
- changes of measured total remifentanil concentration(1 hour after anesthesia induction, 30/60/90 min after the beginning of cardiopulmonary bypass, 1 hour after the end of cardiopulmonary bypass)
- Median absolute prediction error(during CPB)
研究者
Tae Kyong Kim
Clinical Professor
Seoul National University Hospital