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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
Information provided by:
University of Toronto Identifier:
First received: February 26, 2009
Last updated: June 29, 2010
Last verified: June 2010
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: Double Blind (Subject, Caregiver, 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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00852410

Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M6R 1B5
Sponsors and Collaborators
University of Toronto
Principal Investigator: Ali Moshaver, MD University of Toronto
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. A. Moshaver, University Of Toronto Identifier: NCT00852410     History of Changes
Other Study ID Numbers: 09-0001-A 
Study First Received: February 26, 2009
Last Updated: June 29, 2010

Keywords provided by University of Toronto:
Endoscopic sinus surgery

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Epinephryl borate
Anesthetics, Local
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
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents processed this record on February 20, 2017