Phase 4
N=40
Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
Endoscopic Sinus Surgery · Nasal Polyps
Bottom Line
View on ClinicalTrials.gov: NCT03228914 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale — 3; 2.55 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxymetazoline (Drug); Epinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale |
3; 2.55 | — |
| SECONDARY Amount of Blood Loss in mL |
— | — |
Summary
The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which are 2 different nasal decongestants both of which are routinely used before sinus surgery) on blood loss and the surgeon's view of the surgical field during sinus surgery.
Eligibility Criteria
Inclusion Criteria
- The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery (ESS) in which the same sinuses and procedures on both sides are the same for CRS with or without nasal polyposis.
Exclusion Criteria
- pregnancy
- known coagulopathy
- an international normalized ratio greater than 1.3
- a partial thromboplastin time greater than 50 seconds
- use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)
- use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)
- poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg or greater or a diastolic blood pressure of 90mm Hg or greater
- having any adverse reaction to topical epinephrine or oxymetazoline.
Data sourced from ClinicalTrials.gov (NCT03228914). 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.