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Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery

NCT01075581 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-02-25

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Roee Landsberg, MD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-04-30
Completion
2011-06-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01075581 on ClinicalTrials.gov