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
Recruitment status was Not yet recruiting
Sponsor:
Tel-Aviv Sourasky Medical Center
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
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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:
Drug Information available for:
Epinephrine bitartrate
Epinephrine
Epinephrine hydrochloride
Racepinephrine hydrochloride
Racepinephrine
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:
- 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.
| 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 Epinephryl borate 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 June 17, 2013