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

Completed

• Conditions: Anaesthesia; Surgery

• Registration Number: NCT01077674
• Lead Sponsor: Arvi Yli-Hankala

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morphology of electroencephalogram during discrepancy between Entropy and BIS index values	15 minutes

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland