NCT02566226已完成4 期
Impact of Intrathecal Morphine on Sleep Apnea Syndrome After Hip Arthroplasty Performed Under Spinal Anaesthesia
适应症
干预措施
相关药物
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
Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic episodes is unknown. The objective of this randomised controlled trial is to investigate the effect of intrathecal morphine and surgery on apneic episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physical status I - III
- •patients scheduled to undergo hip arthroplasty
排除标准
- •planned surgical duration more than 3 hours
- •contraindication to spinal anaesthesia
- •severe respiratory disease
- •patient known and treated for sleep apnea syndrome
研究组 & 干预措施
Bupivacaine with normal saline
Placebo Comparator
干预措施: Bupivacaine with normal saline (Drug)
Bupivacaine with intrathecal morphine
Active Comparator
干预措施: Bupivacaine with intrathecal morphine (Drug)
结局指标
主要结局
apnea hypopnea index while lying supine
时间窗: postoperative night 0
次要结局
- mean pulse oxymetry(postoperative night 0)
- Pruritus (yes/no)(postoperative day 0, 1, 2 and 3)
- apnea hypopnea index while lying in another position than supine(postoperative night 0)
- Berlin questionnaire(24 h before surgery)
- STOP-BANG questionnaire(24 h before surgery)
- Epworth questionnaire(24 h before surgery)
- postoperative nausea and vomiting (yes/no)(postoperative day 0, 1, 2 and 3)
- pain scores (numeric rating scale, 0-10)(postoperative day 0, 1, 2 and 3)
- oxycodone consumption (mg)(postoperative day 0, 1, 2 and 3)
研究者
Eric Albrecht
Program Director, Regional Anaesthesia
Centre Hospitalier Universitaire Vaudois
研究点 (1)
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