Impact of Tramadol and Oxycodone on Sleep Apnea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Apnea hypopnea index while lying supine
研究概览
简要总结
Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia
- •physical status I-III
排除标准
- •planned surgical duration more than 3 hours
- •contraindication to spinal anaesthesia
- •severe respiratory disease
- •patient treated for sleep apnea syndrome
- •allergy to tramadol or oxycodone
研究组 & 干预措施
Oxycodone
Postoperative pain treatment with oxycodone
干预措施: Oxycodone (Drug)
Tramadol
Postoperative pain treatment with tramadol
干预措施: Tramadol (Drug)
结局指标
主要结局
Apnea hypopnea index while lying supine
时间窗: Postoperative night 1
Apnea hypopnea index while lying supine
次要结局
- Apnea hypopnea index in another position than supine(Postoperative night 3)
- Mean pulse oxymetry(Postoperative night 3)
- Apnea hypopnea index while lying supine(Postoperative night 3)
- Pains scores (numeric rating scale)(Postoperative day 0, 1, 2 and 3)
- Opioid (oxycodone or tramadol) consumption(Postoperative day 0, 1, 2 and 3)
研究者
Eric Albrecht
Program director of regional anaesthesia
Centre Hospitalier Universitaire Vaudois