Intraoperative M-Entropy Measurements

University of Oklahoma (OU)

Status: Completed

Conditions: General Anesthesia

Treatments: Device: study cases

Study type: Observational

Funder types: Other

Identifiers

NCT00599066

IRB No: 13577

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Study cases

Description:

Application of a second M-Entropy probe on the forehead of the patient; at the end the patient will have 2 probes on the forehead, one in the right and one in the left.

Treatment:

Device: study cases