Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery - Full Text View

Sponsor:	Tel-Aviv Sourasky Medical Center
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT01075581

Purpose

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	Intervention
Hypertension Hypotension Tachycardia Bradycardia Arrhythmia	Drug: Epinephrin (Intranasal injection) Drug: Epinephrin (Topical administration)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Endoscopy High Blood Pressure Low Blood Pressure

Drug Information available for: Epinephrine bitartrate Epinephrine

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

Intraoperative hemodynamic alterations (instability) [ Time Frame: duration of surgery ] [ Designated as safety issue: Yes ]
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:

Hemostasis [ Time Frame: duration of surgery ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	50
Study Start Date:	April 2010
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075581

Contacts

Contact: Roee Landsberg, MD	972524266359	roeel@tasmc.health.gov.il
Contact: Yifat Klein, PhD	97236974093	yifat.klein@gmail.com

Locations

Israel
Tel Aviv Sourasky medical center	Not yet recruiting
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

Investigators

Principal Investigator:

Roee Landsberg, MD

Tel-Aviv Sourasky Medical Center

More Information

No publications provided

Responsible Party:	Dr Roee Landsberg, The Ear, Nose and Throat (ENT) Department - Head and Neck Surgery at the Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT01075581 History of Changes
Other Study ID Numbers:	TASMC-10-RL-0035-CTIL
Study First Received:	February 24, 2010
Last Updated:	February 24, 2010
Health Authority:	Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:

Hemodynamic instability
Hemostasis

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Hypertension
Hypotension
Tachycardia
Bradycardia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Epinephrine
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 09, 2012