Phase 4
N=80
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
Intraoperative Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT05867342 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Surgical Field Grading Score — 3.54; 3.23 score on a scale — p=0.77
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Epinephrin (Drug); 1% lidocaine with epinephrin 1:100,000 (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Field Grading Score |
3.54; 3.23 | 0.77 |
| SECONDARY Duration of Surgery |
72.05; 54.23 | 0.002 sig |
| SECONDARY Number of Extra Pledgets Used |
3.25; 2.63 | 0.126 |
| SECONDARY Estimated Blood Loss During Surgery |
95.25; 91.63 | — |
| SECONDARY Postoperative Bloody Discharge Grading Score |
2.38; 2.2 | 0.213 |
| SECONDARY Number of Days With Postoperative Bloody Nasal Discharge |
2.85; 2.73 | 0.418 |
| SECONDARY Number of Nostrils With Continuous Fresh Bleeding |
7; 5 | 0.756 |
Summary
In endoscopic sinus surgery a clear surgical field of view is a very important aspect for good surgical outcome. This study is to evaluate the preoperative preparation to acquire best surgical field of view by comparing between the use of topical adrenaline and the use of combination of topical adrenaline with infiltration of 1% lidocaine with adrenaline in patients scheduled for endoscopic sinus surgery for rhinosinusitis.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery
Exclusion Criteria
- Patients who have asymetrical disease on the two sides (Lund Mackay score difference more than 2)
- Patients who have endoscopic sinus surgery for treatment of tumor or disease other than sinusitis
- Patients with underlying uncontrolled hypertension
- Patients with bleeding disorder or are unable to discontinue antiplatelet or anticoagulant before the surgery
- Patients who are allergic to adrenaline or to xylocaine
Data sourced from ClinicalTrials.gov (NCT05867342). 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.