Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2017
CompletedResults Posted
Study results publicly available
September 18, 2018
CompletedSeptember 18, 2018
September 1, 2018
1.4 years
May 15, 2015
August 7, 2018
September 17, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Blood Pressure Following Oxymetazoline 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.
5 - 150 mins. after administration
Heart Rate Following Oxymetazoline 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.
5 - 150 mins. after administration
Secondary Outcomes (2)
Ease of Hemostasis
intraoperative
Amount of Bleeding
intraoperative
Study Arms (3)
FESS
ACTIVE COMPARATORPatients undergoing functional endoscopic sinus surgery and receiving oxymetazoline as part of their surgery.
Turbinates
ACTIVE COMPARATORPatients undergoing turbinate reduction surgery and receiving oxymetazoline as part of their surgery.
Adenoidectomy
ACTIVE COMPARATORPatients undergoing an adenoidectomy and receiving oxymetazoline as part of their surgery.
Interventions
Eligibility Criteria
You may qualify if:
- Patients that are scheduled for:
- Functional endoscopic sinus surgery
- Turbinate reduction (with or without tonsillectomy and/or adenoidectomy)
- Adenoidectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Cartabuke, MD
- Organization
- Nationwide Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Cartabuke, MD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Co-Director of Outpatient Anesthesia Services
Study Record Dates
First Submitted
May 15, 2015
First Posted
May 27, 2015
Study Start
December 1, 2015
Primary Completion
April 20, 2017
Study Completion
April 20, 2017
Last Updated
September 18, 2018
Results First Posted
September 18, 2018
Record last verified: 2018-09