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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hartmut Gehring, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01766999
First received: January 4, 2013
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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
- Methemoglobinemia

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Correlation between hemoximetric and pulseoximetric measured methemoglobin [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time course of MetHb concentration following liposuction employing tumescent anesthesia. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 133
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
SpMetHb > 8%
hemoximetric MetHb measurements triggered

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

- female patients scheduled for liposuction

Criteria

Inclusion Criteria:

  • planned liposuction in tumescent local anesthesia

Exclusion Criteria:

  • hematologic disorders
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hartmut Gehring, Prof. Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01766999     History of Changes
Other Study ID Numbers: MetHb02
Study First Received: January 4, 2013
Last Updated: January 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:
pulse oximetry
tumescent anesthesia

Additional relevant MeSH terms:
Methemoglobinemia
Hematologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014