The Pharmacokinetic and Pharmacodynamics Profiles of Remifentanil 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
- 30
- 主要终点
- Change in respiratory rate from baseline over time - OSA Group
研究概览
简要总结
This investigation tested the hypothesis that children with obstructive sleep apnea have an increased pharmacodynamic sensitivity to the miotic and respiratory depressant effects of the prototypic μ-opioid agonist remifentanil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •8-14 years old
- •ASA physical status 1 or 2
- •undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea
排除标准
- •Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)
- •Control (Non-OSA) Group:
- •Inclusion Criteria:
- •8-14 years old
- •ASA physical status 1 or 2
- •no known obstructive sleep apnea presenting for any procedure requiring general anesthtic
- •Exclusion Criteria:
- •Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)
研究组 & 干预措施
OSA Group
a) Children 8-14 years old, b) ASA physical status 1or 2, c) undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea
干预措施: Remifentanil Infusion (Drug)
Control (non-OSA) Group
a) Children 8-14 years old, b) ASA physical status 1or 2, c) no known obstructive sleep apnea presenting for any procedure requiring general anesthetic
干预措施: Remifentanil Infusion (Drug)
结局指标
主要结局
Change in respiratory rate from baseline over time - OSA Group
时间窗: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Respiratory monitoring was performed using nasal cannula
Change in pupil diameter from baseline over time - OSA Group
时间窗: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Change in pupil diameter from baseline over time - Control (non-OSA) Group
时间窗: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Change in end-expired carbon dioxide from baseline over time - OSA Group
时间窗: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
End-expired carbon dioxide monitoring using bedside monitoring
Change in end-expired carbon dioxide from baseline over time - Control (non-OSA) Group
时间窗: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
End-expired carbon dioxide monitoring using bedside monitoring
Change in respiratory rate from baseline over time - Control (non-OSA) Group
时间窗: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Respiratory monitoring was performed using nasal cannula
Remifentanil plasma concentration - OSA Group
时间窗: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
3ml blood draw
Remifentanil plasma concentration - Contro (non-OSA) Group
时间窗: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
3ml blood draw
次要结局
未报告次要终点