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.|
|ClinicalTrials.gov 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
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|
|Hypertension Hypotension Tachycardia Bradycardia Arrhythmia||Drug: Epinephrin (Intranasal injection) Drug: Epinephrin (Topical administration)|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- Hemostasis [ Time Frame: duration of surgery ]
Hemostatic effects will be evaluated by the following parameters:
- By the surgeon, via a subjective surgical grade scoring system.
- By the extent of nasal bleeding (estimated by assessment of the suction bottles, sponges, and the surgical drapes and gowns).
- By the total number of epinephrin pledgets used during surgery.
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 ClinicalTrials.gov identifier (NCT number): NCT01075581
|Contact: Roee Landsberg, MDfirstname.lastname@example.org|
|Contact: Yifat Klein, PhDemail@example.com|
|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|
|Principal Investigator:||Roee Landsberg, MD||Tel-Aviv Sourasky Medical Center|