Esmolol vs. Labetalol in Endoscopic Sinus Surgery

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661346
• Other study ID #: 15-0309
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: March 2017
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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.

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• Labetalol
Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
• Esmolol
Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rate of Blood Loss	milliliters per minute	Duration of operation up to 3 hours
Secondary	Average Mean Arterial Blood Pressure	units of mmHg, measured throughout operation	Duration of operation up 3 hours/completion of operation
Secondary	Average Heart Rate	units of beats per minute, measured throughout the operation	Duration of operation up to 3 hours/completion of surgery