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

Phase 4

Completed

• Conditions: Endoscopic Sinus Surgery; Nasal Polyps
• Interventions: Drug: Epinephrine; Drug: Oxymetazoline

• Registration Number: NCT03228914
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-25
• Study Start: 2018-06-14
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Results First Submitted: 2020-01-30
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Results First Posted: 2021-01-13
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epinephrine	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.
Oxymetazoline	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States