The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery
1 other identifier
interventional
140
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2009
CompletedFirst Posted
Study publicly available on registry
February 27, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 30, 2010
June 1, 2010
1.1 years
February 26, 2009
June 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of Intraoperative bleeding
during surgery
Secondary Outcomes (1)
hemodynamic fluctuation
during surgery
Study Arms (2)
1% lidocaine with 1:100000 adrenaline
ACTIVE COMPARATORhigh dose adrenaline
1% lidocaine with 1:200,000 adrenaline
ACTIVE COMPARATORlow dose
Interventions
1% lidocaine with 1:200,000 adrenaline
Eligibility Criteria
You may qualify if:
- recurrent acute sinusitis, chronic sinusitis, or nasal polyposis
You may not qualify if:
- bleeding disorders, under age of 18, history of cardiac disease or on antihypertensive medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Toronto
Toronto, Ontario, M6R 1B5, Canada
Related Publications (1)
Moshaver A, Lin D, Pinto R, Witterick IJ. The hemostatic and hemodynamic effects of epinephrine during endoscopic sinus surgery: a randomized clinical trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):1005-9. doi: 10.1001/archoto.2009.144.
PMID: 19841339DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Moshaver, MD
University of Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 26, 2009
First Posted
February 27, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
June 30, 2010
Record last verified: 2010-06