Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01075581
First received: February 24, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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:


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
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 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:
Hypertension
Hypotension
Tachycardia
Bradycardia
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014