Esmolol vs. Labetalol in Endoscopic Sinus Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-03-30

Brief Summary

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

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Detailed Description

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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

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Chronic Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Esmolol

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

Group Type EXPERIMENTAL

Esmolol

Intervention Type DRUG

Infusion - 0.1mg/kg/min

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

Labetalol

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

Group Type ACTIVE_COMPARATOR

Labetalol

Intervention Type DRUG

Aliquots of 20mg of Labetol

• Maximum Dose - 300mg total for case

Interventions

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Labetalol

Aliquots of 20mg of Labetol

• Maximum Dose - 300mg total for case

Intervention Type DRUG

Esmolol

Infusion - 0.1mg/kg/min

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No