The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery

University of Toronto

Status and phase: Unknown; Phase 3

Conditions: Chronic Sinusitis

Treatments: Drug: 1% lidocaine with 1:200,000 adrenaline; Drug: 1% lidocaine with 1:100,000 adrenaline

Study type: Interventional

Funder types: Other

Identifiers

NCT00852410

09-0001-A

Details and patient eligibility

About

Obtaining adequate hemostasis is crucial during endoscopic sinus surgery. Submucosal injection of local anaesthetic containing adrenaline has frequently been used to improve surgical milieu. However, injection of adrenaline has potential side effects including tachycardia, hypertension as well as inducing arrhythmia. The aim of this randomized clinical trial is to assess the hemodynamic and hemostatic effects of two different concentrations of adrenaline in local anaesthetic used during endoscopic sinus surgery.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• recurrent acute sinusitis, chronic sinusitis, or nasal polyposis

Exclusion criteria

• bleeding disorders, under age of 18, history of cardiac disease or on antihypertensive medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups

1% lidocaine with 1:100000 adrenaline

Active Comparator group

Description:

high dose adrenaline

Treatment:

Drug: 1% lidocaine with 1:100,000 adrenaline

1% lidocaine with 1:200,000 adrenaline

Active Comparator group

Description:

low dose

Treatment:

Drug: 1% lidocaine with 1:200,000 adrenaline