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Intraoperative M-Entropy Measurements

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ClinicalTrials.gov Identifier: NCT00599066
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

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

Condition or disease Intervention/treatment
General Anesthesia Device: study cases

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
Actual Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Same-patient Reproducibility of Intraoperative M-Entropy Measurements
Study Start Date : September 2007
Primary Completion Date : June 2008
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599066


Locations
United States, Oklahoma
OU MEDICAL CENTER, Presbyterian Tower, OR
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Mehemet Ozcan, MD The University of Oklahoma Health Sciences Center, Department of Anesthesiology

Publications:
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00599066     History of Changes
Other Study ID Numbers: IRB No: 13577
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Oklahoma:
M-Entropy