Endoscopic Sinus SurgeryPhase 4NCT03228914

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

A Phase 4 study testing Oxymetazoline and Epinephrine in people with Endoscopic Sinus Surgery and Nasal Polyps, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Endoscopic Sinus Surgery, Nasal Polyps
What is being tested?: Oxymetazoline and Epinephrine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 14 Jun 2018to 29 Aug 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Endoscopic Sinus Surgery, Nasal Polyps
Being tested: Oxymetazoline, Epinephrine
Medical subject headings: Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxymetazolineDrug
Also called Afrin
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.
EpinephrineDrug
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.

Study groups in NCT03228914
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Epinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: during surgery approximately 2-3 hours

Secondary outcomes (1)

Amount of Blood Loss in mL
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.
Measured: immediately at the completion of surgery (surgery lasts about 2-3 hours, and the suctioning stops immediately following the completion of the case)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 201829 Aug 2018

First posted25 Jul 2017
Study start14 Jun 2018
Primary completion29 Aug 2018
Study completion29 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Endoscopic Sinus SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03228914
Sponsor's protocol ID: HSC-MS-17-0415
Status last verified: Jan 2021
First submitted: 14 Jul 2017
Last updated: 13 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
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FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
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In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy
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Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
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Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS
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All Endoscopic Sinus Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
ClinicalTrials.gov ID: NCT03228914
Acronym / sponsor ID: HSC-MS-17-0415
Conditions: Endoscopic Sinus Surgery, Nasal Polyps
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 14 Jun 2018 (actual)
Primary completion: 29 Aug 2018 (actual)
Study completion: 29 Aug 2018 (actual)
First posted: 25 Jul 2017 (actual)
Results: Posted 13 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Oxymetazoline	Active comparator	Drug: OxymetazolinePledgets 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.
Epinephrine	Active comparator	Drug: EpinephrinePledgets 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxymetazolineAlso: AfrinPledgets 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
EpinephrinePledgets 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

Primary outcome

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).

1 secondary outcome

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)

Results and safety

Results posted to the registry on 13 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxymetazoline	20	20
Epinephrine	20	20

Primary outcome: Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale

Time frame: during surgery approximately 2-3 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Oxymetazoline n = 20	Epinephrine n = 20
Value	3 (0.19)	2.55 (0.15)

Population analysed: For each participant who started the study, oxymetazoline was administered to one side of the nasal cavity and epinephrine was administered to the other side of the nasal cavity. Each participant has two sides of the nasal cavity, and each participant received both oxymetazoline and epinephrine, one drug per side.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: adverse event was collected during the surgical case on the day the patient was enrolled. (2-3hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxymetazoline	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Epinephrine	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Endoscopic Sinus Surgery

Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruitingEarly Phase 1
In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy
Endonasal Surgery, Endoscopic Sinus Surgery
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
Recruiting
Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS
Fospropofol Disodium

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William C Yao, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale (time frame: during surgery approximately 2-3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03228914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.