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The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esmolol | Experimental | Patients receiving esmolol when intra-operative MAP > 80 mmHg. |
|
| Labetalol | Active Comparator | Patients receiving labetalol when intra-operative MAP > 80 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labetalol | Drug | Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case |
| |
| 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)
| 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)
| Duration of operation up to 3 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamad Chaaban, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77550 | United States |
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3 months to 3 years at time of publication (if applicable)
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| ID | Title | Description |
|---|---|---|
| FG000 | Esmolol | Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min |
| FG001 | Labetalol | Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with chronic rhinosinusitis undergoing FESS
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| ID | Title | Description |
|---|---|---|
| BG000 | Esmolol | Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min |
| BG001 | Labetalol | Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)
| Those analyzed had complete data | Posted | Mean | Standard Deviation | score on a scale | Duration of operation |
|
Adverse events collected following surgery in recovery room
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esmolol | Patients receiving esmolol when intra-operative MAP > 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohamad Chaaban | University of Texas Medical Branch - Galveston | 281-338-0829 | mrchaaba@UTMB.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2018 | Sep 4, 2018 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 23, 2016 | Jan 19, 2021 | Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 16, 2017 | Jan 19, 2021 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D007741 | Labetalol |
| C036604 | esmolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Esmolol |
| Drug |
Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Labetalol | Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case |
|
|
| Primary | 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)
| Those included had complete data | Posted | Mean | Standard Deviation | score on a scale | Duration of operation up to 3 hours |
|
|
|
| Secondary | Rate of Blood Loss | milliliters per minute | Those included had complete data | Posted | Mean | Standard Deviation | mL/min | Duration of operation up to 3 hours |
|
|
|
| Secondary | Average Mean Arterial Blood Pressure | units of mmHg, measured throughout operation | Those included had complete data | Posted | Mean | Standard Deviation | mmHg | Duration of operation up 3 hours/completion of operation |
|
|
|
| Secondary | Average Heart Rate | units of beats per minute, measured throughout the operation | Those included had complete data | Posted | Mean | Standard Deviation | bpm | Duration of operation up to 3 hours/completion of surgery |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Labetalol | Patients receiving labetalol when intra-operative MAP > 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case | 0 | 15 | 0 | 15 | 0 | 15 |
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| D012457 |
| Salicylamides |
| D000577 | Amides |
| D000588 | Amines |