Respiratory Impact of Short Life Agents Used in Balanced Anesthesia on Patients Suffering or Suspected of Obstructive Sleep Apnea (OSA) Syndrome
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
- Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position
研究概览
简要总结
The investigators aim to assess the respiratory effect of short half-life agents in balanced anesthesia on patients suffering from non-treated or suspected obstructive sleep apnea syndrome (OSA) We will study the impact on OSA of a regimen of remifentanil-desflurane versus a regimen of fentanyl-sevoflurane. Each patient will undergo three respiratory portable polygraphies: the night before the surgery ; the first night following the surgery ; the third night following the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Physical status I - III
- •Patient scheduled to undergo lower limb orthopedic surgery
- •Patients known for non-treated obstructive sleep apnea or suspected of having an obstructive sleep apnea
排除标准
- •Patients known for treated obstructive sleep apnea ;
- •Severe respiratory disease (i.e., chronic obstructive pulmonary disease, asthma, pulmonary fibrosis);
- •Severe cardiovascular disease
- •Chronic use of opiates ≥ 30mg/j morphine eq.
- •Chronic use of benzodiazepine
- •Inability to consent
研究组 & 干预措施
SEVO-FENTA
Patients scheduled for lower limb surgery will receive a balanced anesthesia with fentanyl and sevoflurane.
干预措施: Fentanyl and sevoflurane (Drug)
DES-REMI
Patients scheduled for lower limb surgery will receive a balanced anesthesia with remifentanil and desflurane.
干预措施: Remifentanil and desflurane (Drug)
结局指标
主要结局
Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position
时间窗: postoperative night 1
次要结局
- Postoperative nausea and vomiting (yes/no)(postoperative day 0,1,2 and 3)
- Percentage of time with saturation < 90%(postoperative night 1 and night 3)
- Percentage of time in obstructive apnea(postoperative night 1 and night 3)
- Sleep Apnea screening questionnaire (NOSAS questionnaire)(24h before surgery)
- Pain scores (numeric rating scale, 0-10)(postoperative day 0,1,2 and 3)
- Pruritus (yes/no)(postoperative day 0,1,2 and 3)
- Mean oxygen saturation(postoperative night 1 and night 3)
- Total sleep duration(postoperative night 1 and night 3)
- Number of apnea and hypopnea events per hour of sleep (Apnea-Hypopnea index) in supine position(postoperative night 1 and night 3)
- Mean amplitude of desaturation (AD%)(postoperative night 1 and night 3)
- Percentage of time in mixt apnea(postoperative night 1 and night 3)
- Sleep Apnea screening questionnaire (Epworth questionnaire)(24h before surgery)
- Number of obstructive apnea events(postoperative night 1 and night 3)
- Percentage of time in supine position(postoperative night 1 and night 3)
- Percentage of time in central apnea(postoperative night 1 and night 3)
- Sleep Apnea screening questionnaire (STOP BANG questionnaire)(24h before surgery)
- Sleep Apnea screening questionnaire (Berlin questionnaire)(24h before surgery)
- Level of satisfaction (visual analog scale)(postoperative day 3)
- Opiate consumption (mg morphine)(postoperative day 0,1,2 and 3)
研究者
Eric Albrecht
PD Dr
Centre Hospitalier Universitaire Vaudois