Intraoperative M-Entropy Measurements | Clinical Trial

Key information

Conditions

General Anesthesia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OU MEDICAL CENTER, Presbyterian Tower, OR

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

study cases

Device

Application 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.

Other names: M-entropy module (Datex-Ohmeda S/5 EntropyTM Module)

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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Same-patient Reproducibility of Intraoperative M-Entropy Measurements

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Jan 23, 2008
Registry last updated: Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed