Pharmacokinetic/Pharmacodynamic Modeling of Morphine for Postoperative Analgesia Through a Patient Controlled Device After Coronary Artery Bypass Grafting. Intrathecal Morphine Significantly Reduces Drug Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- PK/PD modelling
研究概览
简要总结
The currently available data are insufficient to develop a model that achieves optimum morphine dose individualization at the postoperative period of coronary artery bypass grafting (CABG). Therefore, the objective of the study was to apply a PK/PD model that could justify morphine consumption, drug plasma concentration and pain intensity during the postoperative period after CABG and evaluate the post operative pain.
详细描述
The protocol was a prospective, open-label study, approved by the institutional ethical committee of the hospital where the study was performed. Patients were randomly assigned to receive general anesthesia plus intrathecal morphine at a dosage of 400 mcg (morphine group) or general anesthesia alone (control group) according to a simple computer-generated list.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •eligible to cardiopulmonary artery bypass grafting surgery
排除标准
- •fraction of ejection below 40%
- •contraindications to neuraxial blockage
- •coagulopathy
- •use of low-weight heparin
- •warfarin or a platelet aggregation inhibitor other than aspirin,
- •systemic or local infection
- •and patients with a specific contraindication on the medication employed in the study
结局指标
主要结局
PK/PD modelling
时间窗: 2 days
From the begin of surgery until 36 hours of postoperative period
Postoperative pain
时间窗: two days
From the end of surgery until 36 hours of postoperative period
次要结局
- PK parameter: Tmax (time to achieve the maximum concentration)(2 days)
- PK parameter: Cmax (peak plasma concentration)(2 days)
- PK parameter: AUC (area under the plasma cocentration versus time curve)(2 days)
研究者
Silvia Regina Cavani Jorge Santos
Chair Professor
University of Sao Paulo