Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Surgical Field Grading Score
研究概览
简要总结
In endoscopic sinus surgery a clear surgical field of view is a very important aspect for good surgical outcome. This study is to evaluate the preoperative preparation to acquire best surgical field of view by comparing between the use of topical adrenaline and the use of combination of topical adrenaline with infiltration of 1% lidocaine with adrenaline in patients scheduled for endoscopic sinus surgery for rhinosinusitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery
排除标准
- •Patients who have asymetrical disease on the two sides (Lund Mackay score difference more than 2)
- •Patients who have endoscopic sinus surgery for treatment of tumor or disease other than sinusitis
- •Patients with underlying uncontrolled hypertension
- •Patients with bleeding disorder or are unable to discontinue antiplatelet or anticoagulant before the surgery
- •Patients who are allergic to adrenaline or to xylocaine
研究组 & 干预措施
Endoscopic sinus surgery
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS).
干预措施: Epinephrin (Drug)
Endoscopic sinus surgery
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS).
干预措施: Saline (Drug)
结局指标
主要结局
Surgical Field Grading Score
时间窗: postoperatively (approximately 20 minutes to assess)
The video recording of the endoscopic sinus surgery of the participant was graded by another otolaryngology specialist postoperatively and graded according to Wormald Surgical Field Grading Scale. Scores range from 0 (no bleeding) to 10 (severe bleeding with nasal cavity filling rapidly).
次要结局
- Duration of Surgery(intraoperatively (up to 3 hours))
- Postoperative Bloody Discharge Grading Score(1 week after the surgery (up to 2 minutes to complete assessment))
- Estimated Blood Loss During Surgery(intraoperatively (up to 3 hours))
- Number of Extra Pledgets Used(intraoperatively (up to 3 hours))
- Number of Nostrils With Continuous Fresh Bleeding(1 week after the surgery (up to 2 minutes to complete assessment))
- Number of Days With Postoperative Bloody Nasal Discharge(1 week after the surgery (up to 2 minutes to complete assessment))
研究者
Peter Hwang
Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Stanford University