Back to resultsThe Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery
Primary Purpose
Chronic Sinusitis
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
1% lidocaine with 1:100,000 adrenaline
1% lidocaine with 1:200,000 adrenaline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis focused on measuring Endoscopic sinus surgery
Eligibility 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
Sites / Locations
- University of Toronto
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1% lidocaine with 1:100000 adrenaline
1% lidocaine with 1:200,000 adrenaline
Arm Description
high dose adrenaline
low dose
Outcomes
Primary Outcome Measures
Reduction of Intraoperative bleeding
Secondary Outcome Measures
hemodynamic fluctuation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00852410
Brief Title
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery
Official Title
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
Endoscopic sinus surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1% lidocaine with 1:100000 adrenaline
Arm Type
Active Comparator
Arm Description
high dose adrenaline
Arm Title
1% lidocaine with 1:200,000 adrenaline
Arm Type
Active Comparator
Arm Description
low dose
Intervention Type
Drug
Intervention Name(s)
1% lidocaine with 1:100,000 adrenaline
Intervention Description
high dose
Intervention Type
Drug
Intervention Name(s)
1% lidocaine with 1:200,000 adrenaline
Intervention Description
1% lidocaine with 1:200,000 adrenaline
Primary Outcome Measure Information:
Title
Reduction of Intraoperative bleeding
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
hemodynamic fluctuation
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Moshaver, MD
Phone
250-276-5050
Email
moshaver@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Moshaver, MD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Moshaver, MD
Phone
250-276-5050
Email
moshaver@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ali Moshaver, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19841339
Citation
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.
Results Reference
derived
Learn more about this trial
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery
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