Phase 4 N=45 Randomized Single-blind Other

Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

Chronic Sinusitis

Bottom Line

View on ClinicalTrials.gov: NCT01706952 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: 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 units on a scale — p=0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cocaine (Drug); Adrenaline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Marc Tewfik
Primary completion: Dec 2013

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01706952). 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.