Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Respiratory depression following opioids
研究概览
简要总结
Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity
详细描述
Ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and especially in opioid naïve patients. Recent evidence in children suggests that patients with moderate to severe OSA may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have OSA. However, what is not known is wether the degree of hypoxemia experienced by patients effects the opioid sensitivity. The aim of this study is to identify if children with known OSA experience a difference in opioid induced respiratory depression based on the degree of hypoxemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
The participant will be unaware of the arm
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing tonsillectomy or adenotonsillectomy
- •Ages 2 to up to 8 years
- •Preoperative sleep study demonstrating obstructive sleep apnea
- •Intubation without medication (e.g. no propofol prior to intubation)
- •Requirement for airway instrumentation: LMA or ETT
- •Inhalation induction of anesthesia
排除标准
- •No obstructive sleep apnea
- •Central sleep apnea events >5/hour
- •IV induction of anesthesia
- •Syndromic patients
- •Known or suspected difficult airway
- •Allergy to Fentanyl
- •Known cardiovascular medications
- •Pulmonary hypertension
- •Total intravenous anesthesia required
- •Parental refusal
研究组 & 干预措施
Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kg
Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.
干预措施: Fentanyl Citrate (Drug)
Patients with sleep apnea having oxygen Saturation <85% randomized to 1.0 mcg/kg fentanyl
Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes
干预措施: Fentanyl Citrate (Drug)
Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.5/kg
Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.
干预措施: Fentanyl Citrate (Drug)
Patients with sleep apnea having oxygen Saturation <85% randomized to 1.5 mcg/kg fentanyl
Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.
干预措施: Fentanyl Citrate (Drug)
结局指标
主要结局
Respiratory depression following opioids
时间窗: end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration
Identification of respiratory depression following fentanyl administration by recording the end-tidal co2 prior to and 10 minutes following fentanyl administration
次要结局
未报告次要终点
研究者
Adam Adler MD, MS, FAAP
Associate Professor of Anesthesiology
Baylor College of Medicine