Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery

NCT03228914 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-17-0415
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which are 2 different nasal decongestants both of which are routinely used before sinus surgery) on blood loss and the surgeon's view of the surgical field during sinus surgery.

Conditions

Endoscopic Sinus Surgery; Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale

  The minimum Boezaart Grading Scale score of 0 indicates no bleeding (cadaveric conditions), and the maximum score of 5 indicates severe bleeding (constant suctioning required).

  during surgery approximately 2-3 hours

Secondary Outcomes (1)

• Amount of Blood Loss in mL

  immediately at the completion of surgery (surgery lasts about 2-3 hours, and the suctioning stops immediately following the completion of the case)

Study Arms (2)

Oxymetazoline

ACTIVE COMPARATOR

Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.

Drug: Oxymetazoline

Epinephrine

ACTIVE COMPARATOR

Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.

Drug: Epinephrine

Interventions

Oxymetazoline DRUG

Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.

Also known as: Afrin

Oxymetazoline

Epinephrine DRUG

Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.

Epinephrine

Eligibility Criteria

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

You may not qualify if:

• pregnancy
• known coagulopathy
• an international normalized ratio greater than 1.3
• a partial thromboplastin time greater than 50 seconds
• use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)
• use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)
• poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg or greater or a diastolic blood pressure of 90mm Hg or greater
• having any adverse reaction to topical epinephrine or oxymetazoline.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

Oxymetazoline; Epinephrine

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: William C. Yao, MD
• Organization: The University of Texas Health Science Center at Houston

william.c.yao@uth.tmc.edu

713-500-5410

Study Officials

• William C Yao, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 25, 2017
• Study Start: June 14, 2018
• Primary Completion: August 29, 2018
• Study Completion: August 29, 2018
• Last Updated: January 13, 2021
• Results First Posted: January 13, 2021

Record last verified: 2021-01

Locations

US (1)