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
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