NCT03661346

Esmolol vs. Labetalol in Endoscopic Sinus Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Sinusitis

Interventions

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

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2018-09-07
• Last updated: 2021-02-08
• Results posted: 2021-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study