Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale
研究概览
简要总结
The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which are 2 different nasal decongestants both of which are routinely used before sinus surgery) on blood loss and the surgeon's view of the surgical field during sinus surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery (ESS) in which the same sinuses and procedures on both sides are the same for CRS with or without nasal polyposis.
排除标准
- •pregnancy
- •known coagulopathy
- •an international normalized ratio greater than 1.3
- •a partial thromboplastin time greater than 50 seconds
- •use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)
- •use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)
- •poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg or greater or a diastolic blood pressure of 90mm Hg or greater
- •having any adverse reaction to topical epinephrine or oxymetazoline.
研究组 & 干预措施
Oxymetazoline
Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.
干预措施: Oxymetazoline (Drug)
Epinephrine
Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.
干预措施: Epinephrine (Drug)
结局指标
主要结局
Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale
时间窗: during surgery approximately 2-3 hours
The minimum Boezaart Grading Scale score of 0 indicates no bleeding (cadaveric conditions), and the maximum score of 5 indicates severe bleeding (constant suctioning required).
次要结局
- Amount of Blood Loss in mL(immediately at the completion of surgery (surgery lasts about 2-3 hours, and the suctioning stops immediately following the completion of the case))
研究者
William Yao
Assistant Professor
The University of Texas Health Science Center, Houston