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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-12

Study Completion Date

2018-08-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Intraoperative Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic sinus surgery

Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS).

Group Type EXPERIMENTAL

Epinephrin

Intervention Type DRUG

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

1% lidocaine with epinephrin 1:100,000

Intervention Type DRUG

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

Saline

Intervention Type DRUG

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

Interventions

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Epinephrin

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

Intervention Type DRUG

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)

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

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Adrenaline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No