Comparison of Preoperative Fentanyl Test and A Short OSAS Screening Scale for Identifying Severe Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Sensitivity， specificity ，positive predictive value and negative predictive value，likelihood ratio
研究概览
简要总结
The aim of this study was to estimate and compare the value of the preoperative fentanyl test and the short OSAS screening scale to diagnose severe obstructive sleep apnea；and to observe the required amount of hydromorphone and the adverse respiratory events after adenotonsillectomy.
详细描述
The results of polysomnography were obtained before adenotonsillectomy, and the short OSAS screening scale was completed by the subjects' parents in preoperative interview. All children were induced by sevoflurane inhalation. After eyelash reflex disappeared and pharyngeal airway insertion, giving 1 mcg/kg fentanyl when the End-tidal concentrations of sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable, observing the changes of respiratory rate. Severe OSAS was diagnosed as respiratory rate decreased by more than 50%. Anesthesia was maintained with desflurane and 60% nitrous oxide in oxygen. The children were transferred to the PACU after extubation. The postoperative pain and agitation were assessed according to the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and The Pediatric Anesthesia Emergency Delirium (PAED) score, and all children were given hydromorphone for pain relief according to our protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The American society of anesthesiologists (ASA) class Ⅰ ~ Ⅱ
- •Age greater than or equal to 3 years
- •Children were diagnosed by polysomnography and plan to adenotonsillectomy.
排除标准
- •craniofacial malformations
- •mental retardation
- •BMI > 30 kg/m2
- •Combined with other neuromuscular diseases
- •a recent history of opioid use
研究组 & 干预措施
the short OSAS scale
In preoperative interview，distributing the short OSAS screening scales to children's parents，and the scale was completed preoperative，calculate the score of the scale
干预措施: the short OSAS scale (Other)
fentanyl test
In the operating room，giving 1 mcg/kg fentanyl when the End-tidal concentrations of sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable after eyelash reflex disappeared and pharyngeal airway insertion, observing the changes of respiratory rate
干预措施: fentanyl test (Diagnostic Test)
结局指标
主要结局
Sensitivity， specificity ，positive predictive value and negative predictive value，likelihood ratio
时间窗: 5 months
Compared the diagnostic results of fentanyl test and the short OSAS screening scale with the diagnostic results of golden standard PSG.
次要结局
- hydromorphone requirement in PACU(50 minutes after extubation)
研究者
Xuan Wang
Director，Head of Anesthesiology
Children's Hospital of Fudan University