- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03228914
Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
January 7, 2021 updated by: William Yao, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery (ESS) in which the same sinuses and procedures on both sides are the same for CRS with or without nasal polyposis.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Oxymetazoline
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.
|
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.
Other Names:
|
ACTIVE_COMPARATOR: Epinephrine
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale
Time Frame: during surgery approximately 2-3 hours
|
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).
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during surgery approximately 2-3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of Blood Loss in mL
Time Frame: immediately at the completion of surgery (surgery lasts about 2-3 hours, and the suctioning stops immediately following the completion of the case)
|
The secondary endpoint will be to compare the amount of blood loss use after the use of epinephrine or Oxymetazoline.
This will be done by subtracting the amount of irrigation used from the volume collected in the suction canisters to estimate blood loss.
The Neptune 2 Waste Management System (NWMS, Stryker, Kalamazoo, Michigan), a closed suction system that digitally measures the amount of fluid suctioned will be used for more accurate measuring of fluid suctioned.
Surgery lasts about 2-3 hours, and the suctioning stops immediately following the completion of the case.
|
immediately at the completion of surgery (surgery lasts about 2-3 hours, and the suctioning stops immediately following the completion of the case)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: William C Yao, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 14, 2018
Primary Completion (ACTUAL)
August 29, 2018
Study Completion (ACTUAL)
August 29, 2018
Study Registration Dates
First Submitted
July 14, 2017
First Submitted That Met QC Criteria
July 21, 2017
First Posted (ACTUAL)
July 25, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 13, 2021
Last Update Submitted That Met QC Criteria
January 7, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Pathological Conditions, Anatomical
- Nose Diseases
- Polyps
- Nasal Polyps
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Epinephrine
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- HSC-MS-17-0415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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