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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014