ClinicalTrials.gov
ClinicalTrials.gov Menu

Esmolol vs. Labetalol in Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03661346
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Drug: Labetalol Drug: Esmolol Phase 2

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  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blood Loss and Visibility With Esmolol vs. Labetalol in Endoscopic Sinus Surgery: A Randomized Trial
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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





Primary Outcome Measures :
  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)

    1. = slight bleeding with no suction required
    2. = slight bleeding with occasional suctioning required
    3. = slight bleeding with frequent suctioning required
    4. = moderate bleeding with frequent suctioning required and surgical field visibility is compromised when suctioning is removed
    5. = severe bleeding (worst) with constant suctioning required and compromised view

  2. Intra-operative surgical visibility - Wormald scale [ Time Frame: Duration of operation ]

    Standardized scoring systems used by surgeons to rate surgical field quality in FESS:

    Wormald scale (0-10):

    0 = No bleeding (optimal)

    1. = 1-2 points of blood ooze
    2. = 3-4 points of ooze
    3. = 5-6 points of ooze
    4. = 7-8 points of ooze
    5. = 9-10 points of ooze
    6. = >10 points of ooze, obscuring field
    7. = Mild field bleeding with slow post-nasal accumulation
    8. = Moderate field bleeding with moderate post-nasal accumulation
    9. = Moderate-severe field bleeding with rapid post-nasal accumulation
    10. = Severe bleeding (worst) with nose filling rapidly


Secondary Outcome Measures :
  1. Rate of blood loss [ Time Frame: Duration of operation ]
    milliliters per minute

  2. Average mean arterial blood pressure [ Time Frame: Duration of operation ]
    units of mmHg, measured throughout operation

  3. Average heart rate [ Time Frame: Duration of operation ]
    units of beats per minute, measured throughout the operation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661346


Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Mohamad Chaaban, MD University of Texas
  Study Documents (Full-Text)

Documents provided by The University of Texas Medical Branch, Galveston:
Informed Consent Form  [PDF] September 4, 2018
Statistical Analysis Plan  [PDF] September 4, 2018
Study Protocol  [PDF] September 4, 2018


Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03661346     History of Changes
Other Study ID Numbers: 15-0309
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 3 months to 3 years at time of publication (if applicable)

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

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Esmolol
Labetalol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists