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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01766999
Other study ID # MetHb02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2008
Est. completion date December 2010

Study information

Verified date November 2020
Source University Hospital Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date December 2010
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - planned liposuction in tumescent local anesthesia Exclusion Criteria: - hematologic disorders

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Schleswig-Holstein

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between hemoximetric and pulseoximetric measured methemoglobin 24 hours
Secondary Time course of MetHb concentration following liposuction employing tumescent anesthesia. 24 hours
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