Esmolol vs. Labetalol in Endoscopic Sinus Surgery

• Sponsor: The University of Texas Medical Branch, Galveston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03661346
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 2.2

Study Details

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.

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 Design

• Study Type: Interventional
• Actual Enrollment: 28 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: Mar 1, 2017
• Actual Primary Completion Date: Mar 30, 2018
• Actual Study Completion Date: Mar 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Intra-operative Surgical Visibility - Boezaart Scale [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 [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 Outcome Measures

1. Rate of Blood Loss [Duration of operation up to 3 hours]

   milliliters per minute

2. Average Mean Arterial Blood Pressure [Duration of operation up 3 hours/completion of operation]

   units of mmHg, measured throughout operation

3. Average Heart Rate [Duration of operation up to 3 hours/completion of surgery]

   units of beats per minute, measured throughout the operation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

• Statistical Analysis Plan - Sep 4, 2018
• Study Protocol - Jan 23, 2016
• Informed Consent Form - Feb 16, 2017

More Information

Publications

None provided.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03661346
• Other Study ID Numbers: 15-0309
• First Posted: Sep 7, 2018
• Last Update Posted: Feb 8, 2021
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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; Labetalol; Esmolol

Study Results

Participant Flow

Arm/Group Title	Esmolol	Labetalol
Arm/Group Description	Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Period Title: Overall Study
STARTED	13	15
COMPLETED	13	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Esmolol	Labetalol	Total
Arm/Group Description	Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case	Total of all reporting groups
Overall Participants	13	15	28
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 76.9%	9 60%	19 67.9%
>=65 years	3 23.1%	6 40%	9 32.1%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45 (17)	51 (16)	50 (19)
Sex: Female, Male (Count of Participants)
Female	4 30.8%	5 33.3%	9 32.1%
Male	9 69.2%	10 66.7%	19 67.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	13 100%	15 100%	28 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Those analyzed had complete data

Arm/Group Title	Esmolol	Labetalol
Arm/Group Description	Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Measure Participants	13	15
Mean (Standard Deviation) [score on a scale]	3.1 (.69)	3.1 (.89)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Those included had complete data

Arm/Group Title	Esmolol	Labetalol
Arm/Group Description	Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Measure Participants	13	15
Mean (Standard Deviation) [score on a scale]	6.1 (1.7)	5.9 (1.9)

3. Secondary Outcome

Title	Rate of Blood Loss
Description	milliliters per minute
Time Frame	Duration of operation up to 3 hours

Outcome Measure Data

Analysis Population Description

Those included had complete data

Arm/Group Title	Esmolol	Labetalol
Arm/Group Description	Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Measure Participants	13	15
Mean (Standard Deviation) [mL/min]	.59 (.28)	.66 (.37)

4. Secondary Outcome

Title	Average Mean Arterial Blood Pressure
Description	units of mmHg, measured throughout operation
Time Frame	Duration of operation up 3 hours/completion of operation

Outcome Measure Data

Analysis Population Description

Those included had complete data

Arm/Group Title	Esmolol	Labetalol
Arm/Group Description	Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Measure Participants	13	15
Mean (Standard Deviation) [mmHg]	79.7 (7.5)	79.4 (7.7)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Those included had complete data

Arm/Group Title	Esmolol	Labetalol
Arm/Group Description	Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Measure Participants	13	15
Mean (Standard Deviation) [bpm]	72 (8.7)	69 (11.7)

Adverse Events

Time Frame	Adverse events collected following surgery in recovery room
Arm/Group Title	Esmolol		Labetalol
Arm/Group Description	Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min		Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
All Cause Mortality
	Esmolol		Labetalol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/15 (0%)
Serious Adverse Events
	Esmolol		Labetalol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Esmolol		Labetalol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.