Trial · NCT03661346
Esmolol vs. Labetalol in Endoscopic Sinus Surgery
NCT03661346, Phase 2, Completed, The University of Texas Medical Branch, Galveston; results first posted 2021-02-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Esmolol vs. Labetalol in Endoscopic Sinus Surgery. Trials, record NCT03661346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03661346
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Esmolol vs. Labetalol in Endoscopic Sinus Surgery
- NCT number
- NCT03661346
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Conditions
- Chronic Sinusitis
- Interventions
- Labetalol, Esmolol
- First posted
- 2018-09-07
- Last updated
- 2021-02-08
- Results first posted
- 2021-02-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | 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 |
| Secondary | Rate of Blood Loss | Duration of operation up to 3 hours | milliliters per minute |
| Secondary | Average Mean Arterial Blood Pressure | Duration of operation up 3 hours/completion of operation | units of mmHg, measured throughout operation |
| Secondary | Average Heart Rate | Duration of operation up to 3 hours/completion of surgery | units of beats per minute, measured throughout the operation |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intra-operative Surgical Visibility - Boezaart Scale | Duration of operation | Those analyzed had complete data | score on a scale | MEAN |
| PRIMARY | Intra-operative Surgical Visibility - Wormald Scale | Duration of operation up to 3 hours | Those included had complete data | score on a scale | MEAN |
| SECONDARY | Rate of Blood Loss | Duration of operation up to 3 hours | Those included had complete data | mL/min | MEAN |
| SECONDARY | Average Mean Arterial Blood Pressure | Duration of operation up 3 hours/completion of operation | Those included had complete data | mmHg | MEAN |
| SECONDARY | Average Heart Rate | Duration of operation up to 3 hours/completion of surgery | Those included had complete data | bpm | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intra-operative Surgical Visibility - Boezaart Scale | Esmolol | 3.1 | Standard Deviation .69 | score on a scale | |
| Intra-operative Surgical Visibility - Boezaart Scale | Labetalol | 3.1 | Standard Deviation .89 | score on a scale | |
| Intra-operative Surgical Visibility - Wormald Scale | Esmolol | 6.1 | Standard Deviation 1.7 | score on a scale | |
| Intra-operative Surgical Visibility - Wormald Scale | Labetalol | 5.9 | Standard Deviation 1.9 | score on a scale | |
| Rate of Blood Loss | Esmolol | .59 | Standard Deviation .28 | mL/min | |
| Rate of Blood Loss | Labetalol | .66 | Standard Deviation .37 | mL/min | |
| Average Mean Arterial Blood Pressure | Esmolol | 79.7 | Standard Deviation 7.5 | mmHg | |
| Average Mean Arterial Blood Pressure | Labetalol | 79.4 | Standard Deviation 7.7 | mmHg | |
| Average Heart Rate | Esmolol | 72 | Standard Deviation 8.7 | bpm | |
| Average Heart Rate | Labetalol | 69 | Standard Deviation 11.7 | bpm |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Esmolol | 13 | |
| Overall Study | STARTED | Labetalol | 15 | |
| Overall Study | COMPLETED | Esmolol | 13 | |
| Overall Study | COMPLETED | Labetalol | 15 | |
| Overall Study | NOT COMPLETED | Esmolol | 0 | |
| Overall Study | NOT COMPLETED | Labetalol | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esmolol | 0 | 13 |
| Total, all-cause mortality | Labetalol | 0 | 15 |
| Total, other adverse events | Esmolol | 0 | 13 |
| Total, other adverse events | Labetalol | 0 | 15 |
| Total, serious adverse events | Esmolol | 0 | 13 |
| Total, serious adverse events | Labetalol | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Esmolol vs Labetalol: deaths from any cause | Trial comparisons |
| Esmolol vs Labetalol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03661346
GET https://conductscience.org/api/trials/v1/NCT03661346/registered