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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077674
First Posted: March 1, 2010
Last Update Posted: October 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital
  Purpose
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.

Condition
Anaesthesia Surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Bispectral Index and Entropy With Electroencephalogram During Sevoflurane Anaesthesia

Resource links provided by NLM:


Further study details as provided by Arvi Yli-Hankala, Tampere University Hospital:

Primary Outcome Measures:
  • Morphology of electroencephalogram during discrepancy between Entropy and BIS index values [ Time Frame: 15 minutes ]

Enrollment: 65
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Entropy - BIS
Patients undergoing surgery in sevoflurane anaesthesia.

  Eligibility

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Middle aged and elderly surgical patients
Criteria

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
  Contacts and Locations
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): NCT01077674


Locations
Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Arvi Yli-Hankala
Tampere University Hospital
Investigators
Study Chair: Arvi Yli-Hankala, MD Tampere University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arvi Yli-Hankala, Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01077674     History of Changes
Other Study ID Numbers: Kotoe_03
First Submitted: February 26, 2010
First Posted: March 1, 2010
Last Update Posted: October 9, 2013
Last Verified: October 2013

Keywords provided by Arvi Yli-Hankala, Tampere University Hospital:
Electroencephalogram
Entropy
BIS
Sevoflurane

Additional relevant MeSH terms:
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs