NCT01766999

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. 1.to investigate multi-wavelength pulse oximetry as a monitoring method for patients at increased risk for methemoglobinemia.
  2. 2.to illustrate MetHb concentrations over a course of 24 hours after a liposuction employing tumescent anesthesia has been carried out.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

January 4, 2013

Last Update Submit

November 2, 2020

Conditions

Methemoglobinemia

Keywords

pulse oximetrytumescent anesthesia

Outcome Measures

Primary Outcomes (1)

  • Correlation between hemoximetric and pulseoximetric measured methemoglobin

    24 hours

Secondary Outcomes (1)

  • Time course of MetHb concentration following liposuction employing tumescent anesthesia.

    24 hours

Study Arms (1)

SpMetHb > 8%

hemoximetric MetHb measurements triggered

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- female patients scheduled for liposuction

You may qualify if:

  • planned liposuction in tumescent local anesthesia

You may not qualify if:

  • hematologic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Methemoglobinemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 11, 2013

Study Start

August 1, 2008

Primary Completion

May 1, 2009

Study Completion

December 1, 2010

Last Updated

November 3, 2020

Record last verified: 2020-11