Intraoperative M-Entropy Measurements

April 12, 2017 updated by: University of Oklahoma

Same-patient Reproducibility of Intraoperative M-Entropy Measurements

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU MEDICAL CENTER, Presbyterian Tower, OR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that are scheduled to have surgery under general anesthesia for which an intraoperative M-Entropy monitoring is planned. Suitable candidates will be identified by speaking to the attending anesthesiologists working at OU Presbyterian hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study cases
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.
Device: study cases
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Mehemet Ozcan, MD, The University of Oklahoma Health Sciences Center, Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

January 22, 2008

First Posted (ESTIMATE)

January 23, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB No: 13577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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