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The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00852410
First received: February 26, 2009
Last updated: June 29, 2010
Last verified: June 2010

February 26, 2009
June 29, 2010
March 2009
April 2010   (final data collection date for primary outcome measure)
Reduction of Intraoperative bleeding [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00852410 on ClinicalTrials.gov Archive Site
hemodynamic fluctuation [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Sinusitis
  • Drug: 1% lidocaine with 1:100,000 adrenaline
    high dose
  • Drug: 1% lidocaine with 1:200,000 adrenaline
    1% lidocaine with 1:200,000 adrenaline
  • Active Comparator: 1% lidocaine with 1:100000 adrenaline
    high dose adrenaline
    Intervention: Drug: 1% lidocaine with 1:100,000 adrenaline
  • Active Comparator: 1% lidocaine with 1:200,000 adrenaline
    low dose
    Intervention: Drug: 1% lidocaine with 1:200,000 adrenaline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
140
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact: Ali Moshaver, MD 250-276-5050 moshaver@yahoo.com
Canada
 
NCT00852410
09-0001-A
No
Dr. A. Moshaver, University Of Toronto
University of Toronto
Not Provided
Principal Investigator: Ali Moshaver, MD University of Toronto
University of Toronto
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP