Endoscopic Sinus Surgery, Nasal Polyps
Conditions
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.
Interventions
DRUGOxymetazoline
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.
DRUGEpinephrine
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | — | All Participants |
|---|---|---|
| Age, Continuous | — years | — |
| Presence of polyps | — | 20 Participants |
| Race and Ethnicity Not Collected | — Participants | — |
| Region of Enrollment United States | — | 20 Participants |
| Sex: Female, Male Female | — | 0 Participants |
| Sex: Female, Male Male | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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).
Time frame: during surgery approximately 2-3 hours
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxymetazoline | Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale | 3 score on a scale | Standard Deviation 0.19 |
| Epinephrine | Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale | 2.55 score on a scale | Standard Deviation 0.15 |
Secondary
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.
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)
Population: Data was not collected for this measure.