Blood Loss and Visibility With Esmolol vs. Labetalol in Endoscopic Sinus Surgery: A Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Intra-operative Surgical Visibility - Boezaart Scale
研究概览
简要总结
The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery.
详细描述
BACKGROUND: Improved intraoperative visibility during functional endoscopic sinus surgery (FESS) decreases the risk of serious orbital or skull base injuries. Beta blockers are among several methods used to reduce mean arterial pressure (MAP), heart rate (HR) and mucosal bleeding. Labetalol (mixed alpha-1-beta blocker) reduces HR and MAP; however, its alpha-1 blockade may mitigate topical epinephrine decongestant effects. Esmolol (selective beta-1 blocker) does not have direct antagonistic effects on topical epinephrine. This study compares the hemodynamic parameters (rate of blood loss, MAP control, HR) and intraoperative visibility during FESS between esmolol and labetalol.
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, 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
- •History of CRS with or without nasal polyps
- •Undergoing FESS for CRS
- •American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient with mild systemic disease).
排除标准
- •Pregnancy
- •Bradycardia
- •Heart failure
- •End stage renal disease
- •Cerebrovascular accident
- •Diabetes mellitus
- •Preoperative use of NSAIDs, aspirin, or beta-blockers
- •Body mass index (BMI) greater than 40 kg/m2.
研究组 & 干预措施
Esmolol
Patients receiving esmolol when intra-operative MAP > 80 mmHg.
干预措施: Esmolol (Drug)
Labetalol
Patients receiving labetalol when intra-operative MAP > 80 mmHg
干预措施: Labetalol (Drug)
结局指标
主要结局
Intra-operative Surgical Visibility - Boezaart Scale
时间窗: Duration of operation
Standardized scoring systems used by surgeons to rate surgical field quality in FESS: Boezaart scale (0-5): 0 = no bleeding (optimal) 1. = slight bleeding with no suction required 2. = slight bleeding with occasional suctioning required 3. = slight bleeding with frequent suctioning required 4. = moderate bleeding with frequent suctioning required and surgical field visibility is compromised when suctioning is removed 5. = severe bleeding (worst) with constant suctioning required and compromised view
Intra-operative Surgical Visibility - Wormald Scale
时间窗: Duration of operation up to 3 hours
Standardized scoring systems used by surgeons to rate surgical field quality in FESS: Wormald scale (0-10): 0 = No bleeding (optimal) 1. = 1-2 points of blood 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 6. = \>10 points of ooze, obscuring field 7. = Mild field bleeding with slow post-nasal accumulation 8. = Moderate field bleeding with moderate post-nasal accumulation 9. = Moderate-severe field bleeding with rapid post-nasal accumulation 10. = Severe bleeding (worst) with nose filling rapidly
次要结局
- Rate of Blood Loss(Duration of operation up to 3 hours)
- Average Mean Arterial Blood Pressure(Duration of operation up 3 hours/completion of operation)
- Average Heart Rate(Duration of operation up to 3 hours/completion of surgery)