Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4)
研究概览
简要总结
Mechanically ventilated patients experiencing pain are frequent in intensive care units (ICU) however their treatment remains unclear. This prospective pharmacodynamic study relates to the analgesia of procedural pains. The primary objective was to determine the 90% effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically ventilated patients.
Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation, reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were included.
During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new LD until BPS was at 3 or 4.
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
- •48th hour of mechanical ventilation
- •mechanical invasive ventilation
- •48th hour midazolam sedation
- •Behavioral Pain Scale (BPS) at 3 or 4
- •mechanical ventilation of 5 days duration
排除标准
- •Pregnant or breast-feeding woman
- •Impossibility of evaluation of the BPS tetraplegia, curare-link , post anoxic coma encephalic death
- •Indication of deep conscious-sedation, malignant cranial trauma, toxic shock, acute respiratory distress syndrome
- •Extra renal clearance OU people in hemodialysis
- •Severe renal failure (creatinine clearance <15ml/min)
- •Severe hepatic failure
- •State of consciousness with impossibility to use self-assessment scale
- •Body mass index >35 ou <18
- •Sufentanil midazolam paracetamol allergy or contraindication
- •Guardianship or confirmed criminal Subject who give his informed consent
- •Morphinic other than sufentanil (morphine, alfentanil fentanyl, remifentanil, nalbuphine, codeine, buprenorphine)
- •Antalgic other than sufentanil and paracetamol ( tramadol nefopam, ketamine, dextropropoxyphene, non steroidal anti-inflammatory drug )
- •MAO inhibitors
研究组 & 干预措施
Sufentanil
干预措施: Sufentanil (Drug)
结局指标
主要结局
The effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4)
时间窗: five days
次要结局
未报告次要终点