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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Nasal Polyps; Endoscopic Sinus Surgery

Treatments: Drug: Epinephrine; Drug: Oxymetazoline

Study type: Interventional

Funder types: Other

Identifiers

NCT03228914

HSC-MS-17-0415

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Oxymetazoline

Active Comparator 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.

Treatment:

Drug: Oxymetazoline

Epinephrine

Active Comparator group

Description:

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.

Treatment:

Drug: Epinephrine