Esmolol vs. Labetalol in Endoscopic Sinus Surgery

Phase 2

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Esmolol	Esmolol	Patients receiving esmolol when intra-operative MAP \> 80 mmHg.
Labetalol	Labetalol	Patients receiving labetalol when intra-operative MAP \> 80 mmHg

Primary Outcome Measures

Name	Time	Method
Intra-operative Surgical Visibility - Boezaart Scale	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	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

Secondary Outcome Measures

Name	Time	Method
Rate of Blood Loss	Duration of operation up to 3 hours	milliliters per minute
Average Mean Arterial Blood Pressure	Duration of operation up 3 hours/completion of operation	units of mmHg, measured throughout operation
Average Heart Rate	Duration of operation up to 3 hours/completion of surgery	units of beats per minute, measured throughout the operation