Esmolol vs. Labetalol in Endoscopic Sinus Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Drug: Esmolol; Drug: Labetalol

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Esmolol; Patients receiving esmolol when intra-operative MAP > 80 mmHg.	Drug: Esmolol; Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min
ACTIVE_COMPARATOR: Labetalol; Patients receiving labetalol when intra-operative MAP > 80 mmHg	Drug: Labetalol; Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Blood Loss	milliliters per minute	Duration of operation up to 3 hours
Average Mean Arterial Blood Pressure	units of mmHg, measured throughout operation	Duration of operation up 3 hours/completion of operation
Average Heart Rate	units of beats per minute, measured throughout the operation	Duration of operation up to 3 hours/completion of surgery

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Mohamad Chaaban, MD, University of Texas

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): March 30, 2018
• Study Completion (ACTUAL): March 30, 2018

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (ACTUAL): September 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympathomimetics; Adrenergic beta-1 Receptor Antagonists; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Labetalol; Esmolol
• Other Study ID Numbers: 15-0309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 3 months to 3 years at time of publication (if applicable)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No