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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) logo

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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