Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Not Applicable

Completed

• Conditions: Adenoidectomy; Functional Endoscopic Sinus Surgery (FESS); Turbinate Surgery
• Interventions: Drug: Oxymetazoline

• Registration Number: NCT02453841
• Lead Sponsor: Richard Cartabuke

Brief Summary

This proposed study will assess the hemodynamic effects and measure the systemic absorption of topically applied oxymetazoline in patients undergoing functional endoscopic sinus surgery, turbinate surgery, or adenoidectomy. These patients will be receiving oxymetazoline as standard of care during the surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-15
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-27
• Study Start: 2015-12
• Primary Completion: 2017-04-20
• Study Completion: 2017-04-20
• Results First Submitted: 2018-08-07
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-17
• Last Update Submitted: 2018-09-17
• Results First Posted: 2018-09-18
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients that are scheduled for:

  1. Functional endoscopic sinus surgery
  2. Turbinate reduction (with or without tonsillectomy and/or adenoidectomy)
  3. Adenoidectomy

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Exclusion Criteria

• Been treated with oral decongestants or antihistamines within 24 hours of surgery
• Are taking anticoagulants
• Have a history of nasal trauma
• Have a history of epistaxis
• Have a history of hypertension or cardiac disease
• Allergy to oxymetazoline

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adenoidectomy	Oxymetazoline	Patients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery.
FESS	Oxymetazoline	Patients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery.
Turbinates	Oxymetazoline	Patients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery.

Primary Outcome Measures

Name	Time	Method
Blood Pressure Following Oxymetazoline Administration	5 - 150 mins. after administration	Blood pressure was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first.
Heart Rate Following Oxymetazoline Administration.	5 - 150 mins. after administration	Heart rate was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first.

Secondary Outcome Measures

Name	Time	Method
Ease of Hemostasis	intraoperative	A six point scale (very easy, easy, usual, some effort, difficult, extremely difficult) completed by the surgeon at the end of surgery.
Amount of Bleeding	intraoperative	A four point scale (none, minimal, moderate/diffuse ooze, severe/brisk) completed by the surgeon after removal of the oxymetazoline soaked pledgets.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States