Chronic Sinusitis
Conditions
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.
Interventions
DRUGLabetalol
Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
DRUGEsmolol
Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. = 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 |
| 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) 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Blood Loss | Duration of operation up to 3 hours | milliliters per minute |
| Average Mean Arterial Blood Pressure | Duration of operation up 3 hours/completion of operation | units of mmHg, measured throughout operation |
| Average Heart Rate | Duration of operation up to 3 hours/completion of surgery | units of beats per minute, measured throughout the operation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| Labetalol Patients receiving labetalol when intra-operative MAP \> 80 mmHg
Labetalol: Aliquots of 20mg of Labetol
• Maximum Dose - 300mg total for case | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | Labetalol | Total | Esmolol |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 9 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 19 Participants | 10 Participants |
| Age, Continuous | 51 Years STANDARD_DEVIATION 16 | 50 Years STANDARD_DEVIATION 19 | 45 Years STANDARD_DEVIATION 17 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 15 participants | 28 participants | 13 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 10 Participants | 19 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 15 |
| other Total, other adverse events | 0 / 13 | 0 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
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) 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
Time frame: Duration of operation
Population: Those analyzed had complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esmolol | Intra-operative Surgical Visibility - Boezaart Scale | 3.1 score on a scale | Standard Deviation 0.69 |
| Labetalol | Intra-operative Surgical Visibility - Boezaart Scale | 3.1 score on a scale | Standard Deviation 0.89 |
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) 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
Time frame: Duration of operation up to 3 hours
Population: Those included had complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esmolol | Intra-operative Surgical Visibility - Wormald Scale | 6.1 score on a scale | Standard Deviation 1.7 |
| Labetalol | Intra-operative Surgical Visibility - Wormald Scale | 5.9 score on a scale | Standard Deviation 1.9 |
Secondary
Average Heart Rate
units of beats per minute, measured throughout the operation
Time frame: Duration of operation up to 3 hours/completion of surgery
Population: Those included had complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esmolol | Average Heart Rate | 72 bpm | Standard Deviation 8.7 |
| Labetalol | Average Heart Rate | 69 bpm | Standard Deviation 11.7 |
Secondary
Average Mean Arterial Blood Pressure
units of mmHg, measured throughout operation
Time frame: Duration of operation up 3 hours/completion of operation
Population: Those included had complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esmolol | Average Mean Arterial Blood Pressure | 79.7 mmHg | Standard Deviation 7.5 |
| Labetalol | Average Mean Arterial Blood Pressure | 79.4 mmHg | Standard Deviation 7.7 |
Secondary
Rate of Blood Loss
milliliters per minute
Time frame: Duration of operation up to 3 hours
Population: Those included had complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esmolol | Rate of Blood Loss | .59 mL/min | Standard Deviation 0.28 |
| Labetalol | Rate of Blood Loss | .66 mL/min | Standard Deviation 0.37 |