Methemoglobinemia Clinical Trial
Official title:
Methemoglobinemia After Liposuction Under Tumescent Local Anesthesia - Timecourse and Diagnostics by Pulse Oximetry and Blood Gas Analysis.
| 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 |
| Verified date | November 2020 |
| Source | University Hospital Schleswig-Holstein |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Schleswig-Holstein |
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
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