The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery - Full Text View

Sponsor:	University of Toronto
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00852410

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 III

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

Drug Information available for: Epinephrine bitartrate Epinephrine Lidocaine

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):

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.

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:

Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Epinephrine
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 08, 2012