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Esmolol vs. Labetalol in Endoscopic Sinus Surgery

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Labetalol
Esmolol
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Esmolol

Labetalol

Arm Description

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

Patients receiving labetalol when intra-operative MAP > 80 mmHg

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Rate of Blood Loss
milliliters per minute
Average Mean Arterial Blood Pressure
units of mmHg, measured throughout operation
Average Heart Rate
units of beats per minute, measured throughout the operation

Full Information

First Posted
August 30, 2018
Last Updated
January 19, 2021
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03661346
Brief Title
Esmolol vs. Labetalol in Endoscopic Sinus Surgery
Official Title
Blood Loss and Visibility With Esmolol vs. Labetalol in Endoscopic Sinus Surgery: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

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

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esmolol
Arm Type
Experimental
Arm Description
Patients receiving esmolol when intra-operative MAP > 80 mmHg.
Arm Title
Labetalol
Arm Type
Active Comparator
Arm Description
Patients receiving labetalol when intra-operative MAP > 80 mmHg
Intervention Type
Drug
Intervention Name(s)
Labetalol
Intervention Description
Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Intervention Type
Drug
Intervention Name(s)
Esmolol
Intervention Description
Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min
Primary Outcome Measure Information:
Title
Intra-operative Surgical Visibility - Boezaart Scale
Description
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
Time Frame
Duration of operation
Title
Intra-operative Surgical Visibility - Wormald Scale
Description
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
Time Frame
Duration of operation up to 3 hours
Secondary Outcome Measure Information:
Title
Rate of Blood Loss
Description
milliliters per minute
Time Frame
Duration of operation up to 3 hours
Title
Average Mean Arterial Blood Pressure
Description
units of mmHg, measured throughout operation
Time Frame
Duration of operation up 3 hours/completion of operation
Title
Average Heart Rate
Description
units of beats per minute, measured throughout the operation
Time Frame
Duration of operation up to 3 hours/completion of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Chaaban, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
3 months to 3 years at time of publication (if applicable)

Learn more about this trial

Esmolol vs. Labetalol in Endoscopic Sinus Surgery

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