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Methemoglobinemia After Liposuction - Diagnostic by Pulse Oximetry and Blood Gas Analysis.

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Completed
CT.gov ID
NCT01766999
Collaborator
(none)
133
Enrollment
28
Duration (Months)

Study Details

Study Description

Brief Summary

Tumescent local anesthesia is a procedure which is frequently performed for plastic cosmetic surgical procedures such as liposuction. The subcutaneous adipose tissue is infiltrated with large volumes of a solution which also contain local anesthetics. However local anesthetics, can also lead to a marked production of methemoglobin. New generation pulse oximeters are able to measure SpMetHb non-invasivly.

The aim of this study is:

  1. to investigate multi-wavelength pulse oximetry as a monitoring method for patients at increased risk for methemoglobinemia.

  2. to illustrate MetHb concentrations over a course of 24 hours after a liposuction employing tumescent anesthesia has been carried out.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    133 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Methemoglobinemia After Liposuction Under Tumescent Local Anesthesia - Timecourse and Diagnostics by Pulse Oximetry and Blood Gas Analysis.
    Study Start Date :
    Aug 1, 2008
    Actual Primary Completion Date :
    May 1, 2009
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    SpMetHb > 8%

    hemoximetric MetHb measurements triggered

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between hemoximetric and pulseoximetric measured methemoglobin [24 hours]

    Secondary Outcome Measures

    1. Time course of MetHb concentration following liposuction employing tumescent anesthesia. [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • planned liposuction in tumescent local anesthesia
    Exclusion Criteria:
    • hematologic disorders

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital Schleswig-Holstein

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hartmut Gehring, Prof. Dr. med., University Hospital Schleswig-Holstein
    ClinicalTrials.gov Identifier:
    NCT01766999
    Other Study ID Numbers:
    • MetHb02
    First Posted:
    Jan 11, 2013
    Last Update Posted:
    Nov 3, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Hartmut Gehring, Prof. Dr. med., University Hospital Schleswig-Holstein
    pulse oximetry
    tumescent anesthesia
    Additional relevant MeSH terms:
    Methemoglobinemia

    Study Results

    No Results Posted as of Nov 3, 2020