The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery

Chronic Sinusitis Clinical Trial

Official title:

The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00852410
• Other study ID #: 09-0001-A
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 26, 2009
• Last updated: June 29, 2010
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: University of Toronto
• Contact: Ali Moshaver, MD
• Phone: 250-276-5050
• Email: moshaver[@]yahoo.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis

Intervention

Drug:
• 1% lidocaine with 1:100,000 adrenaline
high dose
• 1% lidocaine with 1:200,000 adrenaline
1% lidocaine with 1:200,000 adrenaline

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Intraoperative bleeding		during surgery	Yes
Secondary	hemodynamic fluctuation		during surgery	Yes