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

Surgery Clinical Trial

Official title:

Comparison of Bispectral Index and Entropy With Electroencephalogram During Sevoflurane Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077674
• Other study ID #: Kotoe_03
• Status: Completed
• Phase: N/A
• First received: February 26, 2010
• Last updated: October 8, 2013
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: October 2013
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaesthesia
• Surgery

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Arvi Yli-Hankala	Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphology of electroencephalogram during discrepancy between Entropy and BIS index values		15 minutes	No