Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery

NCT01075581 | Unknown

• 1 other identifier: TASMC-10-RL-0035-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension; Hypotension; Tachycardia; Bradycardia; Arrhythmia

Keywords

Hemodynamic instability; Hemostasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Hemostasis

  duration of surgery

Study Arms (2)

Topical administration

ACTIVE COMPARATOR

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)

Intranasal injection

EXPERIMENTAL

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)

Interventions

Epinephrin (Intranasal injection) DRUG

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.

Also known as: Adrenaline

Intranasal injection

Epinephrin (Topical administration) DRUG

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.

Also known as: Adrenaline

Topical administration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients scheduled for endoscopic resection of a tumor or closure of a cerebrospinal fluid leak, and
• Patients for whom epinephrine was contraindicated.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky medical center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Hypertension; Hypotension; Tachycardia; Bradycardia; Arrhythmias, Cardiac

Interventions

Epinephrine; Administration, Topical

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Roee Landsberg, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roee Landsberg, MD

CONTACT

972524266359; roeel@tasmc.health.gov.il

Yifat Klein, PhD

CONTACT

97236974093; yifat.klein@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 25, 2010

Record last verified: 2010-02

Locations

IL (1)