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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Endoscopy Sinusitis
U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Reduction of Intraoperative bleeding [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hemodynamic fluctuation [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Toronto

Additional 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
Study First Received: February 26, 2009
Last Updated: June 29, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Endoscopic sinus surgery

Additional relevant MeSH terms:
Nose Diseases
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Epinephrine
Epinephryl borate
Lidocaine
Hemostatics
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on May 16, 2013