Clinical Trials Directory

Trials / Completed

CompletedNCT00599066

Intraoperative M-Entropy Measurements

Same-patient Reproducibility of Intraoperative M-Entropy Measurements

Status
Completed
Phase
Study type
Observational
Enrollment
24 (actual)
Sponsor
University of Oklahoma · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to learn more about an Entropy monitor that the anesthesiologist will be using.

Detailed description

Depth of anesthesia monitors are increasingly used in clinical anesthesia practice. Bispectral Index (BIS) and M-Entropy are examples to these devices, both of which are available at our institution. Both BIS and M-Entropy use a unilateral, single channel of EEG to derive a number indicating the anesthetic depth. These devices have similar disposable skin probes that can be applied on either side of the forehead. Since the depth of anesthesia for an individual is the same over the whole brain cortex at a given point in time, BIS numbers obtained over the left and right side of the forehead should agree. The same should be true for M-Entropy as well. A recent study, however, showed that two separate BIS probes, applied over the left and right forehead of the same patient at the same time, can give significantly different numbers. This has not been studied for M-Entropy. BIS and M-Entropy use different mathematical algorithms that process the raw EEG signal to compute a numeric value. Therefore, it is possible that M-Entropy may show different results in a similar study setup. The aim is to investigate the same-patient reproducibility of M-Entropy by monitoring and recording Entropy variables over both the left and the right side of the forehead of patients under general anesthesia.

Conditions

Interventions

TypeNameDescription
DEVICEstudy casesApplication of a second M-Entropy probe on the forehead of the patient, which will happen in the OR along with the application of other monitors immediately before induction of general anesthesia.

Timeline

Start date
2007-09-01
Primary completion
2008-06-01
Completion
2009-04-01
First posted
2008-01-23
Last updated
2017-04-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00599066. Inclusion in this directory is not an endorsement.