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Completed

NCT Number: NCT03228914

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

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.

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Key information

Conditions

Endoscopic Sinus Surgery Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxymetazoline

Drug

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

Epinephrine

Drug

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Amount of Blood Loss in mL

    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)

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 25, 2017
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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