Phase 4
Completed N=45
Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery
Chronic Sinusitis
Source: ClinicalTrials.gov NCT01706952 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case). — 2.17; 2.04 units on a scale — p=0.05
◆ Published Evidence
Established
32citations · ~3 / year
Topical cocaine vs adrenaline in endoscopic sinus surgery: a blinded randomized controlled study.
Summary
The purpose of our study is to assess the effect of topical vasoconstriction (cocaine 4% versus adrenaline 1/1000) on the surgical field during endoscopic sinus surgery.
Linked Publications
-
Topical cocaine vs adrenaline in endoscopic sinus surgery: a blinded randomized controlled study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case). |
2.17; 2.04 | 0.05 |
| SECONDARY Heart Rate |
74.68; 73.62 | — |
| SECONDARY Blood Pressure |
68.02; 68.41 | — |
| SECONDARY End Tidal CO2 |
32.26; 31.69 | — |
Eligibility Criteria
Inclusion Criteria
- Patients older than 18 years undergoing bilateral ESS for chronic sinusitis.
Exclusion Criteria
- Patients with heart disease
- History of bleeding diathesis
- Patients with untreated or poorly controlled high blood pressure
- Aspirin, anticoagulant or natural herbal medication usage in the last 4 weeks
- Hypersensitivity to adrenaline or cocaine
- Significant asymmetry between the right and left side disease extent as determine by findings on their pre-operative CT scan and nasal endoscopy.
Data sourced from ClinicalTrials.gov (NCT01706952) and the linked publication. 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. Informational only — not medical advice.