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Completed

NCT Number: NCT03661346

Esmolol vs. Labetalol in Endoscopic Sinus Surgery

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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Key information

Conditions

Chronic Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Medical Branch

Galveston, Texas, 77550, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

labetalol

Drug

Aliquots of 20mg of Labetol

  • Maximum Dose - 300mg total for case

esmolol

Drug

Infusion - 0.1mg/kg/min

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

Primary outcomes

  1. Intra-operative Surgical Visibility - Boezaart Scale

    Time frame: Duration of operation

    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

  2. Intra-operative Surgical Visibility - Wormald Scale

    Time frame: Duration of operation up to 3 hours

    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

Secondary outcomes

  1. Rate of Blood Loss

    Time frame: Duration of operation up to 3 hours

    milliliters per minute

  2. Average Mean Arterial Blood Pressure

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

    units of mmHg, measured throughout operation

  3. Average Heart Rate

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

    units of beats per minute, measured throughout the operation

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2018
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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