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Clinical Trials/NCT00599066
NCT00599066CompletedNot Applicable

Same-patient Reproducibility of Intraoperative M-Entropy Measurements

University of Oklahoma1 site in 1 country24 target enrollmentStarted: September 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
The investigators hypothesize that simultaneous M-Entropy measurements from the left and right side of the forehead of a person do not differ during general anesthesia.

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients scheduled to have surgery under general anesthesia, with a minimum of 60 minutes expected duration.

Exclusion Criteria

  • Non-English speaker
  • Patients younger than 18 years of age

Outcomes

Primary Outcomes

The investigators hypothesize that simultaneous M-Entropy measurements from the left and right side of the forehead of a person do not differ during general anesthesia.

Time Frame: 1 year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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