Total Intravenous Versus Inhaled Anesthesia in Endoscopic Sinus Surgery for High-Grade Paranasal Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Intraoperative Visual Field Assessment
研究概览
简要总结
Utilization of total intravenous anesthesia (TIVA) has been proposed as a method to improve visualization during endoscopic sinus surgery (ESS), largely due to its physiologic decrease in cardiac output without the peripheral smooth muscle relaxation and resultant vasodilation associated with inhaled anesthetics. This may be especially important in cases of advanced inflammatory sinus disease, when visualization may be most compromised. The goal of this study is to improve clinical practice paradigms by evaluating the use of TIVA versus inhaled anesthetic for maintenance of anesthesia in ESS for advanced paranasal sinus disease.
详细描述
Specific Aims:
- Determine the effect of total intravenous versus inhaled anesthesia on intraoperative visual field in endoscopic sinus surgery for advanced paranasal sinus disease
- Evaluate clinical outcomes associated with choice of total intravenous versus inhaled anesthesia in endoscopic sinus surgery
General Design:
Double blind, randomized controlled trial of total intravenous versus inhaled anesthetic for maintenance of anesthesia during endoscopic sinus surgery.
Subject Recruitment and Screening:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing endoscopic sinus surgery
- •Advanced inflammatory sinus disease, defined as allergic fungal sinusitis, chronic rhinosinusitis with nasal polyposis, chronic rhinosinusitis with eosinophilia, or rhinosinusitis with pan-sinus opacification (Lund-Mackay score >12).
排除标准
- •Noninflammatory sinonasal disease
- •Disease extending through the skull base or orbital wall
- •American Society of Anesthesiologists Preoperative Health Status >II
- •Known non-pharmacologic coagulopathy (platelet < 50000/mL, international normalized ratio > 1.2)
- •Preoperative anticoagulants within 7 days of surgery
- •Allergy to one of the study medications
- •Age under 18 years
- •Non-English-speaking
研究组 & 干预措施
Total Intravenous
Intravenous propofol for maintenance of anesthesia
干预措施: Propofol (Drug)
Inhaled Anesthetic
Inhaled volatile anesthetic for maintenance of anesthesia
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Intraoperative Visual Field Assessment
时间窗: Performed intraoperatively at the end of surgical case
Wormald Visualization Scale (validated) Grade Assessment (0-10) -Higher scores indicate worsening visualization 0 No bleeding 1. 1-2 points of ooze 2. 3-4 points of ooze 3. 5-6 points of ooze 4. 7-8 points of ooze 5. 9-10 points of ooze (sphenoid fills in 60 seconds)\* 6. 10 points of ooze, obscuring surface (sphenoid fills in 50 seconds)\* 7. Mild bleeding/oozing from entire surgical surface with slow accumulation of blood in the post nasal space (sphenoid fills by 40 seconds) 8. Moderate bleeding from entire surgical surface with moderate accumulation of blood in the post nasal space at (sphenoid fills by 30 seconds) 9. Moderately severe bleeding with rapid accumulation of blood in the post nasal space (sphenoid fills by 20 seconds) 10. Severe bleeding with nasal cavity filling rapidly(sphenoid fills in10 seconds)
次要结局
- Sinus-related Quality of Life(3 months and 6 months)
- Intraoperative Blood Loss(At time of surgery)
- Surgical Time(At time of surgery)
- Post-anesthesia Care Unit Recovery Time(Immediately following surgery (postoperative day zero))
- Number of Patients Treated With Post-operative Anti-emetics(24 hours following surgery completion)
研究者
Edward Mccoul, MD
Active Medical Staff
Ochsner Health System