Esmolol vs. Labetalol in Endoscopic Sinus Surgery

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Chronic Sinusitis

Treatments: Drug: Labetalol; Drug: Esmolol

Study type: Interventional

Funder types: Other

Identifiers

NCT03661346

15-0309

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Esmolol

Experimental group

Description:

Patients receiving esmolol when intra-operative MAP \> 80 mmHg.

Treatment:

Drug: Esmolol

Labetalol

Active Comparator group

Description:

Patients receiving labetalol when intra-operative MAP \> 80 mmHg

Treatment:

Drug: Labetalol