Esmolol vs. Labetalol in Endoscopic Sinus Surgery

The University of Texas Medical Branch, Galveston28 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Sinusitis

Interventions

LabetalolDRUG

Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case

EsmololDRUG

Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Texas Medical Branch

Galveston, Texas, United States

Outcomes

Primary Outcomes

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) 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

Time frame: 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. = 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

Time frame: Duration of operation up to 3 hours

Secondary Outcomes

Rate of Blood Loss

milliliters per minute

Time frame: Duration of operation up to 3 hours

Average Mean Arterial Blood Pressure

units of mmHg, measured throughout operation

Time frame: Duration of operation up 3 hours/completion of operation

Average Heart Rate

units of beats per minute, measured throughout the operation

Time frame: Duration of operation up to 3 hours/completion of surgery

Data from ClinicalTrials.gov

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