Hemostatic and Hemodynamic Effects of Intranasal Injection Compared to Topical Administration of Epinephrin in Endoscopic Sinus Surgery
Sponsor study identifier
interventional
50
1 country
1
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2010
Actual (reported)February 25, 2010
Actual (reported)April 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Intraoperative hemodynamic alterations (instability)
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.
duration of surgery
Hemostasis
duration of surgery
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.
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.
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.
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.
Tel Aviv Sourasky medical center
Tel Aviv, 64239, Israel
Roee Landsberg, MD
Tel-Aviv Sourasky Medical Center
First Submitted
February 24, 2010
First Posted
February 25, 2010
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q5
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 25, 2010
Record last verified: 2010-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: