Phase 2
N=28
Esmolol vs. Labetalol in Endoscopic Sinus Surgery
Chronic Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT03661346 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Intra-operative Surgical Visibility - Boezaart Scale — 3.1; 3.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Labetalol (Drug); Esmolol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-operative Surgical Visibility - Boezaart Scale |
3.1; 3.1 | — |
| PRIMARY Intra-operative Surgical Visibility - Wormald Scale |
6.1; 5.9 | — |
| SECONDARY Rate of Blood Loss |
.59; .66 | — |
| SECONDARY Average Mean Arterial Blood Pressure |
79.7; 79.4 | — |
| SECONDARY Average Heart Rate |
72; 69 | — |
Summary
The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03661346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.