Comparison of Two Electroencephalogram (EEG)-Derived Indices With Electroencephalogram Signals

October 8, 2013 updated by: Arvi Yli-Hankala

Comparison of Bispectral Index and Entropy With Electroencephalogram During Sevoflurane Anaesthesia

Bispectral Index (BIS) and Entropy indices will be compared with each other, and to raw EEG signals in patients receiving sevoflurane anaesthesia. BIS and Entropy numbers often differ significantly from each other during surgery, and the reason for this has not been studied in detail, therefore remaining only poorly understood. BIS and Entropy, together with multi-channel EEG, will be collected and analyzed later on. Course of anaesthesia and surgery will be annotated. All relevant information from anaesthesia monitor will be collected on computer.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

65

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

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Middle aged and elderly surgical patients

Description

Inclusion Criteria:

  • Planned surgery necessitating general anaesthesia
  • Expected duration of anaesthesia 30 min or more
  • Need of endotracheal intubation
  • ASA status 1, 2 or 3

Exclusion Criteria:

  • Significant disorders of the autonomic or central nervous system
  • Family history of malignant hyperthermia
  • Clinical history of anaphylactic reaction against inhaled anaesthetics
  • Disability to communicate with Finnish language

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
Entropy - BIS
Patients undergoing surgery in sevoflurane anaesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morphology of electroencephalogram during discrepancy between Entropy and BIS index values
Time Frame: 15 minutes
15 minutes

Collaborators and Investigators

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

Sponsor

Arvi Yli-Hankala

Collaborators

Tampere University Hospital

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

December 1, 2009

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (ESTIMATE)

March 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Kotoe_03

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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