Trial Outcomes & Findings for Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery (NCT NCT03228914)
NCT ID: NCT03228914
Last Updated: 2021-01-13
Results Overview
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).
COMPLETED
PHASE4
20 participants
during surgery approximately 2-3 hours
2021-01-13
Participant Flow
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.
Unit of analysis: one side of nasal cavity
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20 20
|
20 20
|
|
Overall Study
COMPLETED
|
20 20
|
20 20
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data were not collected.
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
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.
|
|---|---|
|
Sex: Female, Male
Female
|
0 Participants
Gender data were not collected as part of the study.
|
|
Sex: Female, Male
Male
|
0 Participants
Gender data were not collected as part of the study.
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
|
Presence of polyps
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: during surgery approximately 2-3 hoursPopulation: 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.
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).
Outcome measures
| Measure |
Oxymetazoline
n=20 one side of nasal cavity
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.
|
Epinephrine
n=20 one side of nasal cavity
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.
|
|---|---|---|
|
Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale
|
3 score on a scale
Standard Deviation 0.19
|
2.55 score on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: immediately at the completion of surgery (surgery lasts about 2-3 hours, and the suctioning stops immediately following the completion of the case)Population: Data was not collected for this measure.
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.
Outcome measures
Outcome data not reported
Adverse Events
Oxymetazoline
Epinephrine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
William C. Yao, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place