Pharmacokinetic-pharmacodynamic Modeling of the Postoperative Pain Sensation During Patient-controlled Analgesia With Target-controlled Infusion of Hydromorphone, Taking Into Account the Interaction With Intraoperatively Administered Sufentanil for Elective Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Plasma concentrations of sufentanil and hydromorphone
研究概览
简要总结
The purpose of this study is to determine generation of a target controlled infusion model for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned open heart surgery, during which the strong analgesic, sufentanil, was used.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent,
- •Ability to understand the nature of patient-controlled analgesia and other study-specific procedures,
- •Elective cardiac surgery with thoracotomy and subsequent stay in the intensive care unit
排除标准
- •Use of MAO inhibitors in the last 14 days,
- •Chronic alcoholism or drug addiction in medical history,
- •Severe obstructive or restrictive pulmonal disorders in medical history,
- •Severe hepatic and renal disorders in medical history,
- •Hypothyroidism, pancreatitis in medical history,
- •Pregnant or nursing females
研究组 & 干预措施
Sufentanil Group 1
Sufentanil Low Titration
干预措施: Sufentanil, Hydromorphone (Drug)
Sufentanil Group 2
Sufentanil High Titration
干预措施: Sufentanil, Hydromorphone (Drug)
结局指标
主要结局
Plasma concentrations of sufentanil and hydromorphone
时间窗: 48 hours
28 blood samples are taken during the study period of 48 hours postoperatively for characterizing the pharmacokinetics
Numerical Rating Scale for Clinical Pain
时间窗: 8 hours
11 assessments of patient's pain sensation using Numerical Rating Scale for Clinical Pain during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the analgesic effect
次要结局
- Total amount of hydromorphone(8 hours)
- Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale(8 hours)