Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery or Adenoidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Blood Pressure Following Oxymetazoline Administration
研究概览
简要总结
This proposed study will assess the hemodynamic effects and measure the systemic absorption of topically applied oxymetazoline in patients undergoing functional endoscopic sinus surgery, turbinate surgery, or adenoidectomy. These patients will be receiving oxymetazoline as standard of care during the surgery.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are scheduled for:
- •Functional endoscopic sinus surgery
- •Turbinate reduction (with or without tonsillectomy and/or adenoidectomy)
- •Adenoidectomy
排除标准
- •Been treated with oral decongestants or antihistamines within 24 hours of surgery
- •Are taking anticoagulants
- •Have a history of nasal trauma
- •Have a history of epistaxis
- •Have a history of hypertension or cardiac disease
- •Allergy to oxymetazoline
研究组 & 干预措施
FESS
Patients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery.
干预措施: Oxymetazoline (Drug)
Turbinates
Patients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery.
干预措施: Oxymetazoline (Drug)
Adenoidectomy
Patients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery.
干预措施: Oxymetazoline (Drug)
结局指标
主要结局
Blood Pressure Following Oxymetazoline Administration
时间窗: 5 - 150 mins. after administration
Blood pressure was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first.
Heart Rate Following Oxymetazoline Administration.
时间窗: 5 - 150 mins. after administration
Heart rate was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first.
次要结局
- Ease of Hemostasis(intraoperative)
- Amount of Bleeding(intraoperative)
研究者
Richard Cartabuke
Co-Director of Outpatient Anesthesia Services
Nationwide Children's Hospital