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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03228914
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Sinus Surgery; Nasal Polyps	Drug: Oxymetazoline; Drug: Epinephrine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 14, 2018
• Actual Primary Completion Date: Aug 29, 2018
• Actual Study Completion Date: Aug 29, 2018

Arms and Interventions

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.	Drug: 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.; Other Names: Afrin
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.	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale [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).

Secondary Outcome Measures

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)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: William C Yao, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 2, 2017

More Information

Publications

None provided.

• Responsible Party: William Yao, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03228914
• Other Study ID Numbers: HSC-MS-17-0415
• First Posted: Jul 25, 2017
• Last Update Posted: Jan 13, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Nasal Polyps; Phenylephrine; Epinephrine; Oxymetazoline

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Oxymetazoline	Epinephrine
Arm/Group Description	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. 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 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: 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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into one side of 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 other side of the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	20 100%
Presence of polyps (Count of Participants)
Count of Participants [Participants]	20 100%

Outcome Measures

1. Primary Outcome

Title	Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale
Description	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).
Time Frame	during surgery approximately 2-3 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Oxymetazoline	Epinephrine
Arm/Group Description	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. 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 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: 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.
Measure Participants	20	20
Measure one side of nasal cavity	20	20
Mean (Standard Deviation) [score on a scale]	3 (0.19)	2.55 (0.15)

2. Secondary Outcome

Title	Amount of Blood Loss in mL
Description	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.
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)

Outcome Measure Data

Analysis Population Description

Data was not collected for this measure.

Arm/Group Title	Oxymetazoline	Epinephrine
Arm/Group Description	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. 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 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: 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.
Measure Participants	0	0

Adverse Events

Time Frame	adverse event was collected during the surgical case on the day the patient was enrolled. (2-3hours)
Adverse Event Reporting Description	Adverse events were collected if there were any deviations to the surgery or patients hemodynamic status while using the pledgets.
Arm/Group Title	Oxymetazoline		Epinephrine
Arm/Group Description	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. 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 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: 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.
All Cause Mortality
	Oxymetazoline		Epinephrine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Oxymetazoline		Epinephrine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Oxymetazoline		Epinephrine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.