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The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of Toronto.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00852410
First Posted: February 27, 2009
Last Update Posted: June 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Toronto
  Purpose
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.

Condition Intervention Phase
Chronic Sinusitis Drug: 1% lidocaine with 1:100,000 adrenaline Drug: 1% lidocaine with 1:200,000 adrenaline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Reduction of Intraoperative bleeding [ Time Frame: during surgery ]

Secondary Outcome Measures:
  • hemodynamic fluctuation [ Time Frame: during surgery ]

Estimated Enrollment: 140
Study Start Date: March 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1% lidocaine with 1:100000 adrenaline
high dose adrenaline
Drug: 1% lidocaine with 1:100,000 adrenaline
high dose
Active Comparator: 1% lidocaine with 1:200,000 adrenaline
low dose
Drug: 1% lidocaine with 1:200,000 adrenaline
1% lidocaine with 1:200,000 adrenaline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852410


Contacts
Contact: Ali Moshaver, MD 250-276-5050 moshaver@yahoo.com

Locations
Canada, Ontario
University of Toronto Recruiting
Toronto, Ontario, Canada, M6R 1B5
Contact: Ali Moshaver, MD    250-276-5050    moshaver@yahoo.com   
Principal Investigator: Ali Moshaver, MD         
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Ali Moshaver, MD University of Toronto
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. A. Moshaver, University Of Toronto
ClinicalTrials.gov Identifier: NCT00852410     History of Changes
Other Study ID Numbers: 09-0001-A
First Submitted: February 26, 2009
First Posted: February 27, 2009
Last Update Posted: June 30, 2010
Last Verified: June 2010

Keywords provided by University of Toronto:
Endoscopic sinus surgery

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Hemostatics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Coagulants
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents