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The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery

Information source: University of Toronto
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Sinusitis

Intervention: 1% lidocaine with 1:100,000 adrenaline (Drug); 1% lidocaine with 1:200,000 adrenaline (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: University of Toronto

Official(s) and/or principal investigator(s):
Ali Moshaver, MD, Principal Investigator, Affiliation: University of Toronto

Overall contact:
Ali Moshaver, MD, Phone: 250-276-5050, Email: moshaver@yahoo.com

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.

Clinical Details

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

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

Primary outcome: Reduction of Intraoperative bleeding

Secondary outcome: hemodynamic fluctuation

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ali Moshaver, MD, Phone: 250-276-5050, Email: moshaver@yahoo.com

University of Toronto, Toronto, Ontario M6R 1B5, Canada; Recruiting
Ali Moshaver, MD, Phone: 250-276-5050, Email: moshaver@yahoo.com
Ali Moshaver, MD, Principal Investigator
Additional Information

Starting date: March 2009
Last updated: June 29, 2010

Page last updated: August 20, 2015

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