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Thyroid Dysfunction in Head and Neck Surgery Patients

Sponsor
University of Arkansas (Other)
Overall Status
Completed
CT.gov ID
NCT00592514
Collaborator
(none)
14
Enrollment
1
Location
36
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Specific Aim I: Determine absorption of iodine after oropharyngeal application of povidone-iodine 10% solution when used in head and neck surgery involving the upper aero-digestive tract.

Specific Aim II: Measurement of iodine induced changes in thyroid function.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Serial blood draws will be obtained from approximately 10 men and women age 18 and over who have been exposed to intraoperative oropharyngeal application with povidone-iodine 10%. Baseline serum and 24-hour urine iodine levels will be measured preoperatively. Serum iodine levels will be drawn at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. A postoperative 24-hour urine iodine level will also be obtained. With the above measurements, the amount of iodine absorption as well as the time period of peak absorption and duration of elevated iodine levels will be elucidated.

    Thyroid hormone metabolism is highly dependent on serum levels of iodine. Thyroid function will be assessed by measuring serum levels of free thyroxine, free triiodothyronine, and thyroid stimulating hormone also at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. Measuring thyroid function is important since hypothyroidism has been known to have a major impact on postoperative wound healing.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    14 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Thyroid Dysfunction in Head and Neck Surgery Patients Treated With Intraoperative Oral Administration With Povidone-iodine 10% Solution
    Study Start Date :
    Jul 1, 2005
    Actual Primary Completion Date :
    Jul 1, 2008
    Actual Study Completion Date :
    Jul 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. Thyroid dysfunction in head and neck surgery patients [Baseline serum and 24-hour urine iodine levels will be measured preoperatively. Serum iodine levels will be drawn at 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours and 1 week after exposure.]

      Specific Aim I: Determine absorption of iodine after oropharyngeal application of povidone-iodine 10% solution when used in head and neck surgery involving the upper aero-digestive tract.

    Secondary Outcome Measures

    1. Thyroid dysfunction in head and neck surgery patients [Thyroid function will be assessed by measuring serum levels of free thyroxine, free triiodothyronine, and thyroid stimulating hormone also at 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours and 1 week after exposure.]

      Specific Aim II: Measurement of iodine induced changes in thyroid function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing any head and neck surgery requiring entry into the upper aerodigestive tract and thus necessitating the oral administration of the antimicrobial agent povidone-iodine 10%.
    Exclusion Criteria:
    • Patients with history of hypothyroidism currently taking thyroid hormone medications (i.e. Synthroid, Levothyroxine, Thyroxine) and women who are pregnant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205

    Sponsors and Collaborators

    • University of Arkansas

    Investigators

    • Principal Investigator: James Suen, MD, University of Arkansas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT00592514
    Other Study ID Numbers:
    • 45976
    First Posted:
    Jan 14, 2008
    Last Update Posted:
    Sep 2, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by University of Arkansas
    Patients undergoing head and neck surgery that involves the upper aerodigestive tract
    Additional relevant MeSH terms:
    Thyroid Diseases

    Study Results

    No Results Posted as of Sep 2, 2011