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

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ClinicalTrials.gov Identifier: NCT01077674
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : October 9, 2013
Sponsor:
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital

Study Description
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Brief Summary:
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 or disease
Anaesthesia Surgery

Study Design
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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Bispectral Index and Entropy With Electroencephalogram During Sevoflurane Anaesthesia
Study Start Date : December 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011
Groups and Cohorts
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Group/Cohort
Entropy - BIS
Patients undergoing surgery in sevoflurane anaesthesia.


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

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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
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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
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Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Arvi Yli-Hankala
Tampere University Hospital
Investigators
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Study Chair: Arvi Yli-Hankala, MD Tampere University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arvi Yli-Hankala, Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01077674    
Other Study ID Numbers: Kotoe_03
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013
Keywords provided by Arvi Yli-Hankala, Tampere University Hospital:
Electroencephalogram
Entropy
BIS
Sevoflurane