Clinical trial

Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery

Name

40274

Description

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.

Trial arms

Trial start

2017-05-12

Estimated PCD

2018-08-22

Trial end

2018-08-22

Status

Completed

Phase

Early phase I

Treatment

Epinephrin

Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity

Arms:

Endoscopic sinus surgery

Other names:

Adrenaline

1% lidocaine with epinephrin 1:100,000

4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site)

Arms:

Endoscopic sinus surgery

Saline

4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)

Arms:

Endoscopic sinus surgery

Size

Primary endpoint

Surgical Field Grading Score

postoperatively (approximately 20 minutes to assess)

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2023-07-10

1 organization

2 products

1 drug

1 indication

Organization

Stanford University

Product

Epinephrin

Indication

Intraoperative Bleeding

Product

1% Lidocaine with Epinephrin

Drug

Varlilumab