Esmolol vs. Labetalol in Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery.

Detailed Description
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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.

Official Title
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Blood Loss and Visibility With Esmolol vs. Labetalol in Endoscopic Sinus Surgery: A Randomized Trial

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Drug: Labetalol
* Drug: Esmolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Pregnancy Asthma COPD 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esmolol<br>Patients receiving esmolol when intra-operative MAP > 80 mmHg. | Drug: Esmolol<br>* Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min<br>|
| Active Comparator: Labetalol<br>Patients receiving labetalol when intra-operative MAP > 80 mmHg | Drug: Labetalol<br>* Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative Surgical Visibility - Boezaart Scale | Standardized scoring systems used by surgeons to rate surgical field quality in FESS: Boezaart scale (0-5): 0 = no bleeding (optimal) = slight bleeding with no suction required = slight bleeding with occasional suctioning required = slight bleeding with frequent suctioning required = moderate bleeding with frequent suctioning required and surgical field visibility is compromised when suctioning is removed = severe bleeding (worst) with constant suctioning required and compromised view | Duration of operation | 
| Intra-operative Surgical Visibility - Wormald Scale | Standardized scoring systems used by surgeons to rate surgical field quality in FESS: Wormald scale (0-10): 0 = No bleeding (optimal) = 1-2 points of blood ooze = 3-4 points of ooze = 5-6 points of ooze = 7-8 points of ooze = 9-10 points of ooze = >10 points of ooze, obscuring field = Mild field bleeding with slow post-nasal accumulation = Moderate field bleeding with moderate post-nasal accumulation = Moderate-severe field bleeding with rapid post-nasal accumulation = Severe bleeding (worst) with nose filling rapidly | Duration of operation up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Blood Loss | milliliters per minute | Duration of operation up to 3 hours | 
| Average Mean Arterial Blood Pressure | units of mmHg, measured throughout operation | Duration of operation up 3 hours/completion of operation | 
| Average Heart Rate | units of beats per minute, measured throughout the operation | Duration of operation up to 3 hours/completion of surgery |