Trial Outcomes & Findings for Esmolol vs. Labetalol in Endoscopic Sinus Surgery (NCT NCT03661346)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Duration of operation

Results posted on

2021-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	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	Labetalol Patients receiving labetalol when intra-operative MAP \> 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Overall Study STARTED	13	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esmolol n=13 Participants Patients receiving esmolol when intra-operative MAP \> 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Labetalol n=15 Participants Patients receiving labetalol when intra-operative MAP \> 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=13 Participants	9 Participants n=15 Participants	19 Participants n=28 Participants
Age, Categorical >=65 years	3 Participants n=13 Participants	6 Participants n=15 Participants	9 Participants n=28 Participants
Age, Continuous	45 Years STANDARD_DEVIATION 17 • n=13 Participants	51 Years STANDARD_DEVIATION 16 • n=15 Participants	50 Years STANDARD_DEVIATION 19 • n=28 Participants
Sex: Female, Male Female	4 Participants n=13 Participants	5 Participants n=15 Participants	9 Participants n=28 Participants
Sex: Female, Male Male	9 Participants n=13 Participants	10 Participants n=15 Participants	19 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	13 participants n=13 Participants	15 participants n=15 Participants	28 participants n=28 Participants

PRIMARY outcome

Timeframe: Duration of operation

Population: Those analyzed had complete data

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

Outcome measures

Outcome measures
Measure	Esmolol n=13 Participants Patients receiving esmolol when intra-operative MAP \> 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Labetalol n=15 Participants Patients receiving labetalol when intra-operative MAP \> 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Intra-operative Surgical Visibility - Boezaart Scale	3.1 score on a scale Standard Deviation .69	3.1 score on a scale Standard Deviation .89

PRIMARY outcome

Timeframe: Duration of operation up to 3 hours

Population: Those included had complete data

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

Outcome measures

Outcome measures
Measure	Esmolol n=13 Participants Patients receiving esmolol when intra-operative MAP \> 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Labetalol n=15 Participants Patients receiving labetalol when intra-operative MAP \> 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Intra-operative Surgical Visibility - Wormald Scale	6.1 score on a scale Standard Deviation 1.7	5.9 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Duration of operation up to 3 hours

Population: Those included had complete data

milliliters per minute

Outcome measures

Outcome measures
Measure	Esmolol n=13 Participants Patients receiving esmolol when intra-operative MAP \> 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Labetalol n=15 Participants Patients receiving labetalol when intra-operative MAP \> 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Rate of Blood Loss	.59 mL/min Standard Deviation .28	.66 mL/min Standard Deviation .37

SECONDARY outcome

Timeframe: Duration of operation up 3 hours/completion of operation

Population: Those included had complete data

units of mmHg, measured throughout operation

Outcome measures

Outcome measures
Measure	Esmolol n=13 Participants Patients receiving esmolol when intra-operative MAP \> 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Labetalol n=15 Participants Patients receiving labetalol when intra-operative MAP \> 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Average Mean Arterial Blood Pressure	79.7 mmHg Standard Deviation 7.5	79.4 mmHg Standard Deviation 7.7

SECONDARY outcome

Timeframe: Duration of operation up to 3 hours/completion of surgery

Population: Those included had complete data

units of beats per minute, measured throughout the operation

Outcome measures

Outcome measures
Measure	Esmolol n=13 Participants Patients receiving esmolol when intra-operative MAP \> 80 mmHg. Esmolol: Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Labetalol n=15 Participants Patients receiving labetalol when intra-operative MAP \> 80 mmHg Labetalol: Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case
Average Heart Rate	72 bpm Standard Deviation 8.7	69 bpm Standard Deviation 11.7

Adverse Events

Esmolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Labetalol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohamad Chaaban

University of Texas Medical Branch - Galveston

Phone: 281-338-0829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place