Text Size

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

This study is currently recruiting participants.
Verified February 2010 by Tampere University Hospital
Sponsor:
Information provided by:
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01077674
First received: February 26, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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:

Drug Information available for: Sevoflurane
U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Morphology of electroencephalogram during discrepancy between Entropy and BIS index values [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Entropy - BIS
Patients undergoing surgery in sevoflurane anaesthesia.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077674

Contacts
Contact: Arvi Yli-Hankala, MD +358331166007 arvi.yli-hankala@uta.fi
Contact: Ville Jäntti, MD +35833116111 ville.jantti@uta.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Arvi Yli-Hankala, MD     +358331166007     arvi.yli-hankala@uta.fi    
Contact: Ville Jäntti, MD     +35833116111     ville.jantti@uta.fi    
Sub-Investigator: Kotoe Kamata, MD            
Sub-Investigator: Antti Aho, MD            
Sub-Investigator: Leo-Pekka Lyytikäinen, MD            
Sub-Investigator: Pasi Puumala, MD            
Sub-Investigator: Maija Vainikka, BSci (med)            
Sponsors and Collaborators
Tampere University Hospital
Investigators
Study Chair: Arvi Yli-Hankala, MD Tampere University Hospital
  More Information

No publications provided

Responsible Party: Arvi Yli-Hankala/Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01077674     History of Changes
Other Study ID Numbers: Kotoe_03
Study First Received: February 26, 2010
Last Updated: February 26, 2010
Health Authority: Finland: Ethics Committee

Keywords provided by Tampere University Hospital:
Electroencephalogram
Entropy
BIS
Sevoflurane

Additional relevant MeSH terms:
Sevoflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013