Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) After 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
- Hydromorphone Plasma Concentrations
研究概览
简要总结
Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target concentrations in blood compared to conventional patient-controlled analgesia after planed 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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age between 40 and 85 years, both genders
- •Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay
排除标准
- •Administration of other analgesics or sedatives, if not administered in stable dosage for at least 14 days or if not used for premedication and surgery
- •Administration of hydromorphone in the period between screening and surgery
- •Severe hepatic or renal impairment in medical history
- •BMI ≥35 kg/m²
研究组 & 干预措施
TCI-PCA
Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion
干预措施: Hydromorphone (Drug)
PCA
Intravenous Patient-Controlled Analgesia
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Hydromorphone Plasma Concentrations
时间窗: Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 17 hours after extubation
Predictive accuracy of the "Erlanger pharmacokinetic model" of hydromorphone administered via TCI, TCI-PCA and conventional PCA during the early postoperative stage
次要结局
- Numerical Rating Score(Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 17 hours after extubation)