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Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery

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. Identifier: NCT01075581
Recruitment Status : Unknown
Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:

Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS) to reduce bleeding in the nasal mucosa and thereby improve visualization of the surgical field. However, systemic absorption of epinephrine via the nasal mucosa is often accompanied by cardiovascular side effects during the early postinjection period, putting in risk patients with cardiovascular morbidity. Evidence indicate that topical administration of epinephrine achieves similar hemostatic effects compared with injection of epinephrine, while avoiding systemic adverse effects. We wish to conduct a prospective controlled trial assessing the hemostatic and hemodynamic effects of intranasal injection compared to topical application of epinephrin during ESS, in order to evaluate whether the previous could be avoided due to its untoward effects.

We hypothesize that topical administration of epinephrine provides a hemostatic effect not inferior to that of intranasal injection while minimizing hemodynamic instability during ESS.

Condition or disease Intervention/treatment Phase
Hypertension Hypotension Tachycardia Bradycardia Arrhythmia Drug: Epinephrin (Intranasal injection) Drug: Epinephrin (Topical administration) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hemostatic and Hemodynamic Effects of Intranasal Injection Compared to Topical Administration of Epinephrin in Endoscopic Sinus Surgery
Study Start Date : April 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : June 2011

Arm Intervention/treatment
Active Comparator: Topical administration
An an intranasal injection of saline will be used as control, and thereafter cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be placed in the nasal cavity during surgery when necessary.
Drug: Epinephrin (Topical administration)
An intranasal injection of saline solution, followed by placement of cotton pledgets (soaked in 1 mL epinephrine 1:1,000) in the nasal cavity when required.
Other Name: Adrenaline

Experimental: Intranasal injection
An intranasal injection of 8 mL epinephrine 1:100,000 will be performed as traditionally practiced in ESS. Thereafter, cotton pledgets soaked in 1 mL epinephrine 1:1,000 will be placed in the nasal cavity during surgery when necessary.
Drug: Epinephrin (Intranasal injection)
A total of 8 mL of epinephrine 1:100,000 will be injected in the lateral nasal wall, followed by placement of cotton pledgets (soaked in 1 mL epinephrine 1:1,000) in the nasal cavity when required.
Other Name: Adrenaline

Primary Outcome Measures :
  1. Intraoperative hemodynamic alterations (instability) [ Time Frame: duration of surgery ]
    Changes in intraoperative hemodynamic parameters will be monitored continuously,and any event will be documented, including: lowest and highest HR, SP and MAP values; mean HR, SP and MAP during surgery; incidence of hypotensive and hypertensive events (>20% relative to baseline); incidence of tachycardic (HR>115) and bradycardic (HR<55) events.

Secondary Outcome Measures :
  1. Hemostasis [ Time Frame: duration of surgery ]

    Hemostatic effects will be evaluated by the following parameters:

    1. By the surgeon, via a subjective surgical grade scoring system.
    2. By the extent of nasal bleeding (estimated by assessment of the suction bottles, sponges, and the surgical drapes and gowns).
    3. By the total number of epinephrin pledgets used during surgery.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with ASA I-III,
  • Patients undergoing elective FESS at Sourasky Medical Center for Chronic rhinosinusitis with or without polyposis, including FESS combined with septoplasty and/or conchotomy.

Exclusion Criteria:

  • Patients scheduled for endoscopic resection of a tumor or closure of a cerebrospinal fluid leak, and
  • Patients for whom epinephrine was contraindicated.

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 identifier (NCT number): NCT01075581

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Contact: Roee Landsberg, MD 972524266359
Contact: Yifat Klein, PhD 97236974093

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Tel Aviv Sourasky medical center
Tel Aviv, Israel, 64239
Sub-Investigator: Ella Feldman, MD         
Sub-Investigator: Yifat Klein, PhD         
Sub-Investigator: Boris Grinshtat, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Principal Investigator: Roee Landsberg, MD Tel-Aviv Sourasky Medical Center
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Responsible Party: Dr Roee Landsberg, The Ear, Nose and Throat (ENT) Department - Head and Neck Surgery at the Tel Aviv Sourasky Medical Center Identifier: NCT01075581    
Other Study ID Numbers: TASMC-10-RL-0035-CTIL
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 2010
Keywords provided by Tel-Aviv Sourasky Medical Center:
Hemodynamic instability
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Cardiac Conduction System Disease
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents